BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE BICLAMP LAPAROSCOPIC INSTRUMENTS

    MDR report key: 6492988 · Received April 14, 2017

    Report

    Report Number
    9610614-2017-00010
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    September 1, 2012
    Report Date
    April 14, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K033421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BICLAMP LAP FORCEPS WERE NOT RETURNED FOR AN EVALUATION. NO EQUIPMENT PROBLEMS OR ISSUES WERE REPORTED. NEVERTHELESS, IT APPEARS THAT THERMAL ENERGY/HEAT FROM THE UNINSULATED HINGE OF A HALF OPEN BICLAMP MOST LIKELY CAUSED THE LESION AND BLEEDING (NOTE: OTHER NON-ELECTROSURGICAL RELATED ISSUES COULD ALSO HAVE CAUSED THE ISSUE.). HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT. DEVICE NOT PROVIDED BY USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BICLAMP LAP FORCEPS, MARYLAND, SERRATED; L: 340 MM, OD 5 MM (LOT NUMBER NOT PROVIDED) WAS USED IN A LYMPHADENECTOMY. DURING THE PROCEDURE, THERE WAS AN UNINTENTIONAL COAGULATION AT THE AORTA CAUSING A LESION AND EXCESSIVE BLEEDING. INTERVENTIONAL WORK WAS NECESSARY TO STOP THE BLEEDING. THE PATIENT RECOVERED WITHOUT FURTHER COMPLICATIONS. NOTE: THE FORCEPS WERE DISTRIBUTED BY A (B)(6) SUBSIDIARY TO THE HOSPITAL IN (B)(6). THE FORCEPS PART NUMBER (P/N) 20195-146 CORRELATES WITH THE ERBE USA DISTRIBUTED P/N 20195-189.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274455 ERBE BICLAMP LAPAROSCOPIC INSTRUMENTS BICLAMP FORCEPS GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention