FDA Adverse Event Malfunction Summary report: N

ACCU-TEMP®

MDR report key: 19655086 · Received July 2, 2024

Report

Report Number
19655086
Event Type
Malfunction
Date Received
July 2, 2024
Date of Event
January 23, 2024
Report Date
February 2, 2024
Manufacturer
BEAVER-VISITEC INTERNATIONAL, INC.
Product Code
HQP
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

BEAVER-VISITEC INTERNATIONAL HOLDINGS, INC. (BVI) ACCU-TEMP LOW TEMPERATURE AND HIGH TEMPERATURE CAUTERY DEVICES APPEAR NEARLY IDENTICAL IN THEIR PACKAGING WHICH CAN LEAD TO CONFUSION WHEN SELECTING ITEMS FOR USE FOR PROCEDURES. THE HANDLE PORTION OF BOTH ITEMS IS WHITE. IN THE PACKAGE, THESE ITEMS ARE ALSO COVERED WITH A WHITE CAP TO PROTECT THE CAUTERY TIP. THE HANDLE DOES HAVE SMALL FONT ON EACH ITEM THAT STATE HIGH OR LOW TEMP, BUT THIS FOUND IS ALSO NEARLY IDENTICAL IN COLOR AND SIZE ON THE TWO ITEMS. IT ISN'T UNTIL THESE ITEMS ARE ON THE SURGICAL FIELD FOR USE WHEN THERE IS A NOTABLE DIFFERENCE; THE HIGH TEMP CAUTERY HAS A BLUE TIP BELOW THE LOOP TIP WHEREAS THE LOW TEMP DEVICE HAS A WHITE OR LIGHT GRAY TIP BELOW THE LOOP. BVI ACCU-TEMP LOW TEMPERATURE CAUTERY; 1/2 IN SHAFT WITH FINE TIP; REF # 8441000; LOT # 6061506 BVI ACCU-TEMP HIGH TEMPERATURE CAUTERY; 1/2 IN SHAFT WITH LOOP TIP; REF # 8443000; LOT # 6053065. A PATIENT WAS HAVING A PROCEDURE OF MEDIAL AND LATERAL RECTUS EXPLORATION /RECESSION FOR EXOTROPIA. A HIGH-TEMP CAUTERY TOOL WAS USED WHEN LOW TEMP CAUTERY TOOL WAS INTENDED. THIS MAY HAVE CONTRIBUTED TO A SMALL SCLERAL LACERATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
756476 ACCU-TEMP® UNIT, CAUTERY, THERMAL, BATTERY-POWERED HQP BEAVER-VISITEC INTERNATIONAL, INC. 8443000 6053065

Patients

Seq Age Sex Outcome Treatment
1 16 YR Male