MAUDE Adverse Event Report: BEAVER VISITEC INTERNATIONAL, INC. ACCU-TEMP CAUTERY, HIGH TEMP, 0.5'' FINE TIP; ACCU-TEMP® CAUTERY, HIGH TEMP, 0.5'' FINE TIP

Catalog Number 8442000

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The bvi accutemp labeling (600076 - ifu) includes the following fire warning: heat generated by the tip can ignite flammable materials.Do not use in the presence of flammable materials such as facial hair, preparation agents, alcohol vapors, drapes, or gowns.Use of the device in an oxygen enriched atmosphere (e.G.Anesthesia) above 21% oxygen concentration can cause fuel sources to ignite, resulting in patient injury.Proper surgical technique, such as the application of water-based lubricant to facial hair near the surgical site of electrocautery use, must be followed to prevent potential patient injury.

Event Description

It was reported a patient's eyelashes and eyebrows allegedly caught fire while the physician was using the bvi accutemp cautery device in the presence of oxygen usage.The fire was extinguished immediately.There was no injury to the patient's skin or eyes, and there was no treatment administered to the patient.The healthcare facility reported that, although the product instructions for use (ifu) calls for the application of water-based lubricant to facial hair near the surgical site, this did not occur during the surgery.

• Brand Name: ACCU-TEMP CAUTERY, HIGH TEMP, 0.5'' FINE TIP
• Type of Device: ACCU-TEMP® CAUTERY, HIGH TEMP, 0.5'' FINE TIP
• Manufacturer (Section D): BEAVER VISITEC INTERNATIONAL, INC.; 500 totten pond rd.; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER VISITEC INTERNATIONAL, INC.; 500 totten pond rd.; 10 citypoint; waltham MA 02451
• Manufacturer Contact: robin rowe ; 500 totten pond rd.; 10 citypoint; waltham, MA 02451 ; 2698065779
• MDR Report Key: 10915152
• MDR Text Key: 219375142
• Report Number: 1211998-2020-00280
• 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
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/17/2023
• Device Catalogue Number: 8442000
• Device Lot Number: 6031864
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• 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