BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAVER-VISITEC INTERNATIONAL, INC

    MDR report key: 20092173 · Received August 28, 2024

    Report

    Report Number
    1211998-2024-00015
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    January 23, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HQP
    UDI-DI
    00886158010241
    PMA / PMN Number
    K771189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BVI QUALITY ASSURANCE DEPARTMENT HAS FOLLOWED ITS INTERNAL PROCEDURE TO INVESTIGATE THE COMPLAINT. THE INVESTIGATION INCLUDED A REVIEW OF CURRENT PROCESS CONTROLS AND THE HISTORICAL DEVICE REGISTER (DHR). ALL MANUFACTURING OPERATIONS WERE RECORDED; ALL SIGNATURES AND DATES WERE PRESENT. NO PRODUCT WAS RETURNED HOWEVER THE CUSTOMER HAS PROVIDED A PHOTOGRAPH FOR EVALUATION. THE PHOTOGRAPH WAS EVALUATED, AND IT IS UNDERSTOOD THAT CONFUSION MAY HAVE ARISEN DUE TO THE SIMILAR PHYSICAL APPEARANCE BETWEEN THE HIGH AND LOW TEMPERATURE CAUTERY TOOLS. HOWEVER, IN THE COURSE OF PERFORMED INVESTIGATION, BVI HAS CLARIFY THAT EACH TOOL IS CLEARLY LABELED WITH ITS SPECIFIC TYPE ON THE BOX AND ON THE PRODUCT ITSELF. IT HAS BEEN THEREFORE CONFIRMED THAT THE LABELS OF BOTH PRODUCTS ARE CORRECTLY MARKED TO AVOID CONFUSION. ACCORDING TO THE ANALYSIS PERFORMED, THE ROOT CAUSE WAS NOT IDENTIFIED DUE TO THE PHOTOGRAPH DEMONSTRATED THAT DEVICE ARE CORRECTLY IDENTIFIED. COMPLAINT DATABASE WAS REVIEWED AND COMPLAINT WAS CONSIDERED AS SINGLE AND ISOLATED. NO FURTHER ACTIONS ARE REQUIRED AT THIS POINT.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER CLARIFIED WITHIN THE REPORT MADE DIRECTLY TO FDA (# (B)(4)) THAT THE NOTIFICATION IS UNRELATED TO THE PATIENT, IT IS IN REFERENCE TO THE NEARLY IDENTICAL PACKAGING OF DEVICES THAT CAN EASILY LEAD TO CONFUSION WHEN SELECTING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464498 BEAVER-VISITEC INTERNATIONAL, INC ACCU-TEMP® CAUTERY, LOW TEMP, 0.5" FINE TIP HQP BEAVER-VISITEC INTERNATIONAL INC 8443000 6053065 00886158010241

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other