BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATING DISPOSABLE BIPOLAR FORCEPS 8 X 0.5MM

    MDR report key: 11553289 · Received March 23, 2021

    Report

    Report Number
    11553289
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 8, 2021
    Manufacturer
    KATALYST SURGICAL LLC
    Product Code
    GEI
    UDI-DI
    00817489027202
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CODMAN IRRIGATING DISPOSABLE BIPOLAR FORCEPS WERE FOUND TO HAVE A 3M INDICATOR/ INSTRUMENT PROTECTOR IN THEM WHERE THE ETHYLENE OXIDE INDICATOR DID NOT CHANGE ON SOME OF THE FORCEPS PACKAGING. CONTACTED CODMAN REP ABOUT THIS ISSUE. THEIR SUPERIOR AND QUALITY DEPARTMENT STATED THE 3M INDICATOR/INSTRUMENT PROTECTOR WERE ONLY PLACE HOLDERS. THE INDICATOR THAT IS USED TO DETERMINE STERILITY IS PLACED ON THE EXTERIOR OF THE CORRUGATED SHIPPING BOX. THE STICKER ON THE OUTSIDE IS PURPLE AND WILL TURN GREEN WHEN IN CONTACT WITH THE ETHYLENE OXIDE (EO). THIS DOT INDICATOR IS USED TO INDICATE STERILIZATION BY EO FOR THESE DISPOSABLES. THERE ARE 5 BIPOLAR FORCEPS (DOUBLE PEEL PACKAGES FOR EACH DISPOSABLE FORCEP) IN A WHITE CARDBOARD BOX AND SEVERAL WHITE CARDBOARD BOXES ARE PACKAGED WITHIN THE CORRUGATED SHIPPING BOX. MULTIPLE REF#S AND LOT#S INVOLVED - 3 EXAMPLES ADDED TO THIS EVENT. THE 3M INDICATOR/INSTRUMENT PROTECTOR HAS 2 YELLOW DIAMONDS FOR EO THAT WILL CHANGE TO RUST/RED IF EXPOSED TO EO APPROPRIATELY. SOME OF THE 3M INDICATORS CHANGED APPROPRIATELY AND SOME REMAINED YELLOW. WE QUESTION IF THE EO GAS EFFECTIVELY PENETRATED THROUGH ALL PACKAGING TO 3M INDICATOR AND IF CONTENTS ARE STERILE. MULTIPLE BOXES OF FORCEPS WERE RETURNED TO CODMAN FOR ANALYSIS. FEEDBACK FROM (B)(4) QUALITY CONTROL STATED THE 3M INDICATOR/ INSTRUMENT PROTECTOR IS ONLY USED AS AN INSTRUMENT PROTECTOR/HOLDER AND THEY NOTED SOME OF THE YELLOW DIAMOND INDICATORS THAT HAD TURNED SLIGHTLY GOLD WERE DETERMINED TO BE RUST IN COLOR AND THEREFORE, STERILE. PICTURES X 4 ATTACHED: #1 PICTURE OF UNCHANGED INDICATOR WITHIN DOUBLE PEEL PACKAGING NEXT TO INDICATOR THAT TURNED RUST/RED AS APPROPRIATE FOR EO STERILIZATION. #2 PICTURE OF CLOSE UP OF UNCHANGED INDICATOR WITHIN PACKAGING. #3 PICTURE OF NEW UNUSED 3M INDICATOR - NOTE YELLOW COLORED DIAMONDS. #4 PICTURE OF USED/CONVERTED 3M INDICATOR - NOTE RUST/RED COLORED DIAMONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451227 IRRIGATING DISPOSABLE BIPOLAR FORCEPS 8 X 0.5MM ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI KATALYST SURGICAL LLC 9008050IR M16373 00817489027202

    Patients

    Seq Age Sex Outcome Treatment
    1