MAUDE Adverse Event Report: CONMED CORPORATION ELECTRODE NEEDLE STD. EXTENDED INSUL.; UNIVERSAL DISPOSABLE ELECTRODE

Catalog Number	138105
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 138105 was received in opened original packaging, the reported catalog and lot numbers were verified.Visual inspection found darkened burn marks along the length of the needle tip and the yellow mold.Visual inspection also found that the shrink tube around the needle tip was deformed (flanged outward).The manufacturing documents of the device history record have been reviewed with special attention to manufacturing and inspection of the product.The product released for distribution was found to have met all the specifications prior to shipment.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 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 instruction for use the user is advised the following: 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.These devices fail the inspection described herein.In the presence of flammable gases, flammable prep solution or drapes, oxidizing gases such as nitrous oxide (n20) or in oxygen-enriched environments.Keep active accessory away from the patient when not in use.An accessory holster may be used to hold active accessories safely.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 138105, needle tip electrode caught on fire.Additional information was gathered, and the event took place on (b)(6) 2018 during a pediatric circumcision.The electrode caught fire at the beginning of the case; the esu settings were 25 cut and 25 coag.The esu and pencil were both conmed devices.The tip and pencil were immediately exchanged out for another of the same device.There was a 5-minute delay in surgery to retrieve the new device.There was no patient injury or impact reported.The procedure was completed as planned.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: ELECTRODE NEEDLE STD. EXTENDED INSUL.
• Common Device Name: UNIVERSAL DISPOSABLE ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8183949
• Report Number: 1320894-2018-00278
• Device Sequence Number: 1850424
• Product Code: GEI
• UDI-Device Identifier: 10653405003410
• UDI-Public: (01)10653405003410(17)230903(30)40(10)201809041
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 09/03/2023
• Device Catalogue Number: 138105
• Device Lot Number: 201809041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR