MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN VERSATRU; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	9008050SL
Medical Device Problem Codes	Overheating of Device (1437); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the codman slim disposable forceps had intermittent power spikes and during use had scorch marks possibly from too high heat transfer.It was reported that it got scorched when the product was used for 2 or 3 hours.Also initial spike was occurred 2 or 3 times.The surgeon commented that a cause of the scorch may be electrical resistance and changing it to silver plating from silver.Additionally, the surgeon advised that coating on the silver is better.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.The product will be returned to your site.
Additional Manufacturer Narrative
It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN VERSATRU
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7722380
• Report Number: 1226348-2018-10515
• Device Sequence Number: 1049769
• Product Code: GEI
• UDI-Device Identifier: 10886704080008
• UDI-Public: (01)10886704080008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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 Catalogue Number: 9008050SL
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1