MAUDE Adverse Event Report: CONMED CORPORATION UNIV. PLUS/MULTI-FUNCTION INST; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-5274-032
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 60-5274-032 was received in opened original packaging, the reported catalog and lot numbers were verified.The device was visually inspected per drawings.The manufacturing process was reviewed regarding the origins of the defect.Visual inspection found that the sheath had become detached from the device and was able to slide along the molded tube.Inspection of the flanged end of the sheath found no evidence of damage or deformation.Possible causes of sheath detachment includes improper seating of the sheath during manufacture (misaligned or improper rotation).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 was 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 24 complaints, regarding (b)(4) devices, for this device family and failure mode.During this 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: cautions and warnings: examine this device prior to use for damage.Do not use if damage is found.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported on behalf of their customer that the 60-5274-032 device shrink sleeve was not fixed into place.It is unknown if this was an obvious failure to the user.This was discovered before surgery and the device was not used; however, a similar failure mode has been reported within the past two years.This report is being raised on the basis of device malfunction.

• Brand Name: UNIV. PLUS/MULTI-FUNCTION INST
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7910330
• Report Number: 1320894-2018-00209
• Device Sequence Number: 1722616
• Product Code: GEI
• UDI-Device Identifier: 00653405010701
• UDI-Public: (01)00653405010701(17)220716(10)201707171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: Health Professional
• Device Expiration Date: 07/16/2022
• Device Catalogue Number: 60-5274-032
• Device Lot Number: 201707171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1