BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSI BLADE

    MDR report key: 11388012 · Received February 26, 2021

    Report

    Report Number
    2434839-2021-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 26, 2021
    Manufacturer
    ACCURATE SURGICAL AND SCIENTIFIC INSTRUMENTS CORP.
    Product Code
    EMF
    UDI-DI
    00841645105244
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER RETURNED THE DAMAGED BLADE AND A BROKEN-OFF PIECE. EVALUATION OF THE DEVICE CONFIRMED THAT NO ADDITIONAL PIECES WERE MISSING. THE DEVICE CONFORMED TO SPECIFICATIONS UPON RELEASE FOR COMMERCIAL DISTRIBUTION. PER PRODUCT LABELING THE SCALPEL BLADE IS INTENDED TO BE HELD WITH A SCALPEL BLADE HOLDER FOR USE DURING SURGICAL PROCEDURES. HOWEVER, DURING THE EVENT OF (B)(6) 2021 THE SURGEON MISUSED THE BLADE BY HOLDING IT AT BOTH ENDS USING TWO HEMOSTATS. HEMOSTATS ARE DEVICES INTENDED TO STOP BLEEDING BY COMPRESSING BLOOD VESSELS. THE EXTREME FORCE EXERTED ON THE EDGE OF THE SCALPEL BLADE BY THIS MISUSE AND BY THE HEMOSTATS CAUSED THE BLADE TO CRIMP AND BREAK.

    Description of Event or Problem · 1

    ACCORDING TO THE USER, DURING A VASOVASOSTOMY THE ASSI CBS-35 BLADE WAS GRASPED WITH TWO CRILE HEMOSTATS AND ONE END OF THE BLADE BROKE OFF IN TWO PIECES. ONE BROKEN-OFF PIECE WAS RETRIEVED IN THE OPERATING ROOM. A POST-OP X-RAY WAS OBTAINED AND A MAGNET WAS PASSED OVER THE OPERATIVE FIELD, BUT NO ADDITIONAL BLADE FRAGMENT WAS FOUND. THE PATIENT WAS RELEASED FROM OUTPATIENT SURGERY ON THE SAME DAY OF THE INCIDENT, (B)(6) 2021. A POST-OP CALL WAS MADE ON (B)(6) 2021 AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286165 ASSI BLADE SCALPEL BLADE EMF ACCURATE SURGICAL AND SCIENTIFIC INSTRUMENTS CORP. 200225 00841645105244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention