MAUDE Adverse Event Report: CONMED CORPORATION ELEC,BLADE,LONG,40; UNIVERSAL DISPOSABLE ELECTRODE

Model Number	138107
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported used device was returned in its original opened package for evaluation.Catalog and lot numbers were verified.Visual inspection observed the blade to have foreign debris at the distal end.The device's hub molding was observed to have discoloration, appearing to have melted or charred.Functional testing with an esu system 7500 and a conmed electrosurgical handpiece observed the reported device to function as expected, producing a stable electrical arc.The most likely cause for this incident was a breach of insulation.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.Of the lot containing (b)(4) units, this is the only complaint for this product and failure mode.A two-year review of complaint history revealed a total of 4 similar complaints, with 3 confirmed devices, have been received for this product and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent.A risk analysis was performed and found this failure mode and occurrence level to be consistent with current risk documents.The instructions for use provides the following warning.- cracked, broken or otherwise distorted plastic parts.- damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.- verify that the electrode is fully and securely seated in the handpiece before use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that during a combined bilateral breast augmentation and abdominoplasty, while cauterizing a sizzling noise was heard, and the 138107 flat blade was observed to have a black ring around the hub.The patient had an area that was reported as a 2nd degree burn in her upper abdomen.The cautery tip was removed from the field and a fresh blade and new generator where used to complete the procedure with a 10-minute surgical delay.Upon clinical assessment, the burn was reported to have been treated with a dressing.The patient recovered from the procedure as expected and with no further complications.The reporter also stated that during the patient's follow up appointment on (b)(6) 2017 the burn was observed to have completely healed.This report is raised based on a reported patient injury.

• Brand Name: ELEC,BLADE,LONG,40
• Common Device Name: UNIVERSAL DISPOSABLE ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7030621
• Report Number: 1320894-2017-00246
• Device Sequence Number: 1183663
• Product Code: GEI
• UDI-Device Identifier: 30653405003421
• UDI-Public: (01)30653405003421(17)220418(10)201704171
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K943542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2022
• Device Model Number: 138107
• Device Catalogue Number: 138107
• Device Lot Number: 201704171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR