MAUDE Adverse Event Report: BEAVER VISITEC INTERNATIONAL, INC ACCU-TEMP; HIGH TEMPERATURE CAUTERY

Model Number 8442000

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

The surgeon was using cautery device when it caught fire, burning the patient's eye lashes and melting the surgeon's glove.No significant harm was noted.The surgeon is unsure whether the device caught fire internally or if the device caught fire upon contact with the patient's eye/eyelash.

• Brand Name: ACCU-TEMP
• Type of Device: HIGH TEMPERATURE CAUTERY
• Manufacturer (Section D): BEAVER VISITEC INTERNATIONAL, INC; 500 trotten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd.; 10 city point; waltham MA 02451
• Manufacturer Contact: robin rowe ; 500 trotten pond rd; 10 citypoint; waltham, MA 02451 ; 2698065779
• MDR Report Key: 12503084
• MDR Text Key: 272417818
• Report Number: 1211998-2021-00056
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K771189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2021

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: 6036171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1