MAUDE Adverse Event Report: CONMED CORPORATION UNIVERSAL MONOPOLAR ACTIVE CORD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	SN-UAC
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was returned to conmed.The device is still under investigation.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed representative reported on behalf of their facility that the sn-uac, universal monopolar cord, made a "pop" noise than a spark during a polypectomy via colonoscopy on (b)(6) 2019.The cord was attached to a snare, the part of the cord that plugs into the snare burned off.The coagulation settings were 15.There was no patient or user impact or injury.The procedure was completed, although not as planned.Another cord was used.This report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Complaint confirmed.Received one sn-uac in opened original packaging.Lot number was able to be verified.Performed a visual inspection of the device, the sn-uac cord had burned in half at the end closest to where you connect the snare.The insulator was stripped off to expose the wires where it had burned and there were not any signs that the burn traveled down the wires.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.(b)(4).Per the instructions for use, the user is advised the following; - these devices are designed for 100 repeated uses when utilized in accordance with the validated instructions.- care in use and handling can extend useful life.- these devices should never be used when there is visible evidence of damage to the exterior of the device such as cracked plastic or connector damage.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: UNIVERSAL MONOPOLAR ACTIVE CORD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8607385
• Report Number: 1320894-2019-00144
• Device Sequence Number: 16729214
• Product Code: GEI
• UDI-Device Identifier: 20653405050220
• UDI-Public: (01)20653405050220(11)181112(30)1(10)201811121
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K020186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: SN-UAC
• Device Lot Number: 201811121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1