MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. ACCU-TEMP; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number 8442000

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Surgeon had to hold down the activation button for a long time to get the handpiece to heat up.Some pushes of the button would work, while other times it wouldn't.This also happened in the previous case.We looked and they were of the same lot#.We opened a handpiece from a different lot# and it worked as it should.Finished case with 2nd handpiece.Pulled the remaining 2 units with that lot# from the stock.

• Brand Name: ACCU-TEMP
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 39 sycamore avenue; little silver NJ 07739
• MDR Report Key: 18502012
• MDR Text Key: 332764522
• Report Number: 18502012
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8442000
• Device Lot Number: 6063955
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1