MAUDE Adverse Event Report: CONMED CORPORATION UNIVERSAL DISPOSABLE ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	138107
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the device and packaging found that the device encroached into the seal area and caused a hole in the poly component of the packaging.Due to the hole in the packaging, the sterility of the device was compromised.A review of the manufacturing documents from the device history record has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.A two-year lot history review was conducted and found a total of three complaints involving three devices for this lot number and failure mode a two-year review of complaint history revealed that there has been a total of 49 complaints, regarding 121 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; these devices should be inspected before and after each use.Visually examine the devices for obvious physical damge including; cracked, broken or otherwise distorted plastic parts.Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported a tear in the pouch.There was no patient impact or injury as it was caught during incoming inspection however, due to the tear not being obvious and the breach in sterility confirmed.This will be reported as a malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL DISPOSABLE ELECTRODE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7923409
• Report Number: 1320894-2018-00212
• Device Sequence Number: 1624768
• Product Code: GEI
• UDI-Device Identifier: 30653405003421
• UDI-Public: (01)30653405003421(17)221023(10)201710241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/23/2022
• Device Model Number: 138107
• Device Catalogue Number: 138107
• Device Lot Number: 201710241
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1