MAUDE Adverse Event Report: CONMED CORPORATION ULTRACLEAN; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	139110EXT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using the bovie with the extender tip when the sheath came off of the extender tip.He then removed the outer sheath of the bovie extender ( ref#: (b)(4)) because it came off from the main shaft of the extender.It was not left in the patient.

• Brand Name: ULTRACLEAN
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 10419772
• Report Number: 10419772
• Device Sequence Number: 14226533
• Product Code: GEI
• UDI-Device Identifier: 40653405007341
• UDI-Public: (01)40653405007341
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/29/2020
• Report Date (Section F): 06/29/2020

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 Model Number: 139110EXT
• Device Catalogue Number: 139110EXT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76
• Date Report Sent to FDA: 06/29/2020