BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE BICLAMP LAP FORCEPS

    MDR report key: 4694765 · Received April 10, 2015

    Report

    Report Number
    9610614-2015-00003
    Event Type
    Other
    Date Received
    April 10, 2015
    Date of Event
    February 18, 2015
    Report Date
    April 10, 2015
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K033421
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BICLAMP LAP FORCEPS WITH INSERT WAS THOROUGHLY INSPECTED. AS REPORTED, THE JAW OF THE INSERT WAS BROKE. THE FORCEPS WITH INSERT WAS MORE THAN SIX (6) YEARS OLD. THE INSTRUMENT SHOWED SIGNIFICANT SIGNS OF USE/WEAR. THE BREAKAGE COULD HAVE BEEN CAUSED BY NORMAL WEAR/FREQUENT USE AND REPROCESSING OVER THE MANY YEARS, OR BY NUMEROUS FORMS OF MISUSE (I.E., BY DROPPING, IMPROPER CLEANING/PROCESSING, MECHANICAL STRESS DURING INSERTION THROUGH THE TROCAR, INCREASED FORCE INTRAOPERATIVELY, ETC.). NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO WHAT CAUSED THE DAMAGE TO THE TINES OF THE INSERT. NEVERTHELESS, IN THE WARNING SECTION OF THE NOTES ON USE (NOU), PRIOR TO USE MEDICAL PERSONNEL ARE TO INSPECT THE PRODUCTS FOR ANY DAMAGE AND NOT USE ANY DAMAGED PRODUCTS. ADDITIONALLY, THE USER IS TO PROTECT THE BICLAMP FROM ANY FORM OF MECHANICAL DAMAGE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORD (DHR). NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED DURING A LAPAROSCOPIC ASSISTED HYSTERECTOMY WITH THE BICLAMP LAP FORCEPS. DURING THE PROCEDURE, ONE OF THE INSERT'S JAWS BROKE OFF INSIDE THE PATIENT. THE PIECE COULD BE SEEN BY X-RAY. SURGICAL INTERVENTION TO REMOVE/RETRIEVE THE BROKEN PART IS PLANNED. CURRENTLY, THERE IS NO INJURY TO THE PATIENT. NOTE: THE BICLAMP LAP FORCEPS, FENESTRATED, SMOOTH, L 340 MM, OD 5 MM [PART NUMBER (P/N) 20195-137, LOT NUMBER (L/N) WO120037] WITH INSERT (P/N 20195-149, L/N OP140261) WAS MANUFACTURED BY OUR PARENT COMPANY (B)(4) AND DISTRIBUTED TO A (B)(6) HOSP. THE FORCEPS WITH INSERT ARE SIMILAR TO THE PRODUCT DISTRIBUTED IN THE U.S. (P/N 20195-192 WITH P/N 20195-185).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238148 ERBE BICLAMP LAP FORCEPS BIPOLAR LAPAROSCOPIC INSTRUMENTS GEI ERBE ELEKTROMEDIZIN GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention