BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BICLAMP LAPAROSCOPIC MARYLAND SERRATED INSERT

    MDR report key: 18091566 · Received November 8, 2023

    Report

    Report Number
    9610614-2023-00054
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K033421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BICLAMP LAPAROSCOPIC INSTRUMENT WAS RETURNED FOR AN EVALUATION. THE BREAKAGE WAS CONFIRMED AS REPORTED. THERE WERE VISIBLE SIGNS OF USE AND WEAR. THERE WAS EVIDENCE OF MECHANICAL DAMAGE IN THE INSERT'S JOINT AREA. A RIVET WAS BROKEN FROM A RIVET HOLE, BUT THE RIVET WAS PRESENT. THE AFFECTED RIVET HOLE WAS TORN OUT AND BENT OPEN IN ONE PLACE, BUT THE DEVICE WAS INTACT (NOTE: THE AFFECTED JOINT IS LOCATED BETWEEN THE FLEXURE PLATE AND THE PUSH ROD. THE ASSOCIATED BRANCH WAS SECURELY ATTACHED TO THE AXLE.). THE GRAY RILSAN COATING (I.E., INSULATION) AND THE GOLD COLORED CERID COATING SHOWED SOME DAMAGE. THERE WAS NO EVIDENCE OF ANY MISSING PARTS OF THE INSERT. A FOREIGN MARKING WAS FOUND ON THE INSERT (I.E., AN UNKNOWN QR CODE). NO OTHER COMPLAINTS HAVE BEEN REPORTED WITH THE INVOLVED LOT AND THERE WERE NO ISSUES WITH THE DEVICE HISTORY RECORD (DHR). BASED UPON THE EVALUATION, IT APPEARS THAT MECHANICAL STRESS (E.G., THROUGH LEVERING, BENDING AND FREQUENT REPROCESSING AND PROGRESSIVE WEAR), WAS THE CAUSE OF THE FAILURE OF THE DEVICE. THE INSTRUMENT MAY HAVE BEEN USED EVEN THOUGH IT WAS PREVIOUSLY DAMAGED. HOWEVER, NO CONCLUSIVE DETERMINATION CAN BE MADE AT THIS TIME. NEVERTHELESS, IN THE DEVICE'S NOTES ON USE, IT IS STATED THAT EXCESSIVE LEVERAGE AND EXCESSIVE (MECHANICAL) FORCES MUST NOT BE EXERTED ON THE INSTRUMENT. THE PRODUCT MUST BE CHECKED FOR DAMAGE BEFORE EACH USE; DEFECTIVE OR DAMAGED PRODUCTS MUST NOT BE USED. THE ENTIRE INSTRUMENT MUST BE PROTECTED FROM MECHANICAL DAMAGE. FREQUENT REPROCESSING AND OPERATIONAL STRESS HAVE AN IMPACT ON THE PRODUCT. IF THERE IS DAMAGE OR FUNCTIONAL IMPAIRMENT, THE PRODUCT MAY NO LONGER BE USED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BICLAMP LAPAROSCOPIC INSTRUMENT BROKE DURING A LAPAROSCOPIC HYSTERECTOMY. THE ACCESSORY WAS BEING USED WITH AN ELECTROSURGICAL UNIT (ESU). SPECIFIC INFORMATION REGARDING THE ESU, SETTINGS, AND OTHER DEVICES USED WERE NOT PROVIDED. DURING THE PROCEDURE, THE JOINT OF THE BICLAMP LAPAROSCOPIC MARYLAND SERRATED INSERT BROKE AND THE BRANCHES COULD NO LONGER BE CLOSED. THE DEVICE WAS UNUSABLE; THEREFORE, THE BRANCHES WERE CLOSED AS MUCH AS POSSIBLE, AND IT WAS REMOVED INTRAPERITONEALLY. THERE WAS NO HARM TO THE PATIENT AND THE OPERATION WAS CONTINUED WITH A REPLACEMENT INSTRUMENT (NOTE: AN X-RAY REVEALED THAT THERE WERE NO MISSING PARTS FROM THE INSTRUMENT LEFT IN THE PATIENT.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744782 ERBE BICLAMP LAPAROSCOPIC MARYLAND SERRATED INSERT BIPOLAR LAPAROSCOPIC INSTRUMENT GEI ERBE ELEKTROMEDIZIN GMBH 706075

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female