MAUDE Adverse Event Report: CONMED CORPORATION 3 1/2" ACCES. BLADE 40/CS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	138113
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in unopened, original packaging.The device catalog and lot numbers were verified.Visual inspection of the device packaging found a breach in the poly side of the packaging near the proximal end of the device.This breach was near the end of the electrode and the breach was likely caused from the inside out by the device.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame 16,000 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: contraindications- these devices should never be used when: there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic or connector damage.-hese devices fail the inspection described herein.Safety tips: inspect and test each device before use.Inspection: these devices should be inspected before each use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts; broken or significantly bent connector contacts; 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 distributor in (b)(6) reported a "tear" on the sterile pouch of device.This would be an obvious defect to the user and was therefore not deemed a reported device failure.However, the complaint device was returned to conmed for evaluation and a hole was found in the packaging that was likely caused by the device.No patient involvement as this defect was found during incoming inspection.This incident will be reported as a device malfunction with potential for injury with reoccurrence.

• Brand Name: 3 1/2" ACCES. BLADE 40/CS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7566919
• Report Number: 1320894-2018-00116
• Device Sequence Number: 2354828
• Product Code: GEI
• UDI-Device Identifier: 30653405003476
• UDI-Public: (01)30653405003476(17)220507(10)201705081
• 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
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: 05/07/2022
• Device Model Number: 138113
• Device Catalogue Number: 138113
• Device Lot Number: 201705081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1