MAUDE Adverse Event Report: CONMED CORPORATION ABC HANDPIECE BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number REF 130344

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Argon bovie handpiece did not work when activated.Fda safety report id # (b)(4).

• Brand Name: ABC HANDPIECE BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 12851904
• MDR Text Key: 281159086
• Report Number: MW5105480
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 130344
• Device Lot Number: 202109204
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1