MAUDE Adverse Event Report: CONMED CONMED HAND-TROL ELECTROSURGICAL HANDPIECE

Model Number	60-0300-501
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) with osa and adenotonsillar hypertrophy taken to operating room for a tonsillectomy and adenoidectomy.Incision made to remove the tonsils using an electro cautery unit.After the removal of the tonsils, burns were noted of the oral commissure.The burn on the right was very superficial.The burn on the left was more significant.The surgeon believes there was a leak of current from the bovie handle that caused the burn.

• Brand Name: CONMED HAND-TROL ELECTROSURGICAL HANDPIECE
• Common Device Name: ELECTROSURGICAL HANDPIECE
• Manufacturer (Section D): CONMED; utica NY 13502
• MDR Report Key: 5771836
• Report Number: MW5063226
• Device Sequence Number: 16299195
• Product Code: GEI
• UDI-Device Identifier: 00653405008265
• UDI-Public: (01)00653405008265
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2016

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 Model Number: 60-0300-501
• Device Catalogue Number: 60-0300-501
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• 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: 7 YR
• Patient Weight: 31