Applied Medical biggest lies!

The QMN Weekly Bulletin Medical Devices / Postmarket Safety
Applied Medical Warned After Patient Death Reports
May 22, 2015



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Inadequate complaint and CAPA procedures following reports of serious incidents including patient deaths led to a warning letter for a California surgical equipment manufacturer.

The April 10 letter followed a Form 483 resulting from a Nov. 3 through Dec. 16, 2014, inspection of Applied Medical Resource’s Santa Margarita, Calif., facility.

According to the investigator from the FDA’s Los Angeles district office, the company failed to adequately evaluate and investigate complaints involving possible failure of a device. Applied Medical didn’t fully document test methods used in its investigations and didn’t provide raw test results or perform trending on multiple, repeat complaint types.

Applied Medical received 94 complaints in 2014 related to buttons on a suction/irrigation device getting stuck in the “on” position. The company also received reports that its Kii Trocar cannula installer malfunctioned. In another customer report involving the company’s Kii Shielded Blade System, the knife didn’t return to the trocar and a patient’s artery was cut, resulting in death a few days later, the warning letter says. In yet another report, a patient died after an artery was cut during introduction of the trocar.

Gary Johnson, group president of Applied Medical’s surgical group, said that the deaths were not caused by failure of device performance. The products used in those cases were returned to Applied Medical and found to meet all applicable specifications and performed as intended.

The two incidents are consistent with the inherent risks of laparoscopic surgery, and user error or abnormal patient anatomy may have contributed, Johnson adds.

The warning letter faults Applied Medical for failing to implement CAPA procedures in response to complaints. Specifically, the company didn’t analyze quality data so that appropriate corrective actions could be identified.

The FDA chides the devicemaker’s design validation procedures, citing a missing “Use by Date” report for the Kii Shielded Blade Access System and missing temperature data for the samples being tested. The investigator asked for the data during the inspection, but it wasn’t provided, the warning letter says.

The company provided temperature logs and said it opened a corrective action request regarding data logging, but the FDA called the response inadequate because it didn’t include the report and lacked acceptance criteria.

Johnson says the company is cooperating with FDA.

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Class 2 Device Recall Voyant Open Fusion Device 22
Date Posted September 15, 2015
Recall Status1 Terminated on November 20, 2015
Recall Number Z-2769-2015
Recall Event ID 7195623
510(K)Number K14351724
Product Classification Electrosurgical, cutting & coagulation & accessories25 - Product Code GEI26
Product Voyant Open Fusion Device
Models: EB040 and EB040+

Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
Code Information Model Number: EB040
Lot Numbers: 1243964, 1243975, 1244125

Model Number: EB040+
Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
Recalling Firm/
Manufacturer Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Karen Mitchell
949-713-8622
Manufacturer Reason
for Recall Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
FDA Determined
Cause 2 Device Design
Action The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to recall60669166@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at lcontursi@appliedmedical.com.
Quantity in Commerce 101 units (U.S) and 38 units (International)
Distribution Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
Total Product Life Cycle TPLC Device Report27
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.5528
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = APPLIED MEDICAL RESOURCES29

 

Uh, nobody ever said there wasn't a recall for the Voyant. I like how you just make up something that's not true so you can show how smart you are and prove it different.

 

Made up something?? Wtf

 

Voyant is a POS

 

and it's a POS because? Seriously, you gotta help me here?

 

Because it's made by Applied Medical

 

Oh of course. Thanks for clearing that up. I thought there might have been a rational reason or something crazy like that.

 

Because none of your accounts are using it.