Accu-Temp® 8441000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30886158010242), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Unclear Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Appropriate Device Problem Term/Code Not Available; Unclear Information; Appropriate Device Problem Term/Code Not Available; Unclear Information

  PER UF REPORT (B)(4). 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.

  Patient problems: Laceration(s)

  MAUDE report 20092173 ↗