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

Model Number 8442000

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

When surgeon attempting to use cautery, stated it was not heating up as it should.It was inconsistently heating up, had to push button hard and/or wait a long time for the wire to ignite.Able to use for case.

• Brand Name: ACCU-TEMP
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond road; 10 citypoint; waltham MA 02451
• MDR Report Key: 18613253
• MDR Text Key: 334203218
• Report Number: 18613253
• 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

• 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: 01/31/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1