MAUDE Adverse Event Report: MEDTRONIC INC. BOVIE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WITH GROUND PAD LOT 211212020(1ST) 21330322(2

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Laceration(s) (1946)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

One of two unipolar machines reported by surgeon to have malfunctioned, and so unable to complete taking out last 5% of bladder tumor.Switched machines at some point.Cut into part of bladder wall tissue.Was likely to return for surgery despite this event.

• Brand Name: BOVIE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 15369817
• MDR Text Key: 299378602
• Report Number: 15369817
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2022,08/24/2022

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
• Device Model Number: WITH GROUND PAD LOT 211212020(1ST) 21330322(2
• Device Lot Number: SEE ABOVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Date Report to Manufacturer: 09/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA
• Patient Sex: Male