BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE BICLAMP LAPAROSCOPIC INSTRUMENTS

    MDR report key: 6180528 · Received December 16, 2016

    Report

    Report Number
    9610614-2016-00031
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 16, 2016
    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 (AND ESUS) WERE NOT RETURNED FOR AN EVALUATION. HOWEVER, A SHORT VIDEO OF THE PROCEDURE WAS PROVIDED. NO EQUIPMENT PROBLEMS OR ISSUES WERE OBSERVED. NONETHELESS DURING THE ESOPHAGECTOMY AND INSTRUMENT ACTIVATION, THE VIDEO SHOWS THAT THE NON-INSULATED HINGE OF THE FORCEPS INADVERTENTLY CONTACTED THE PATIENT'S TRACHEA. IT APPEARS THAT THERMAL ENERGY/HEAT MOST LIKELY CAUSED NECROSIS AND THE DELAYED PERFORATION (NOTE: OTHER NON-ELECTROSURGICAL RELATED ISSUES COULD ALSO HAVE CAUSED THE PERFORATION.). THEREFORE, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. A REVIEW OF DEVICE HISTORY RECORDS (DHRS) FOR THE POSSIBLE INVOLVED GENERATORS DID NOT REVEAL ANY ANOMALIES. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT

    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 LAPAROSCOPIC ESOPHAGECTOMY. THE INSTRUMENT WAS USED IN ASSOCIATION WITH AN ERBE ELECTROSURGICAL UNIT (ESU), MODEL VIO 300 D. ON (B)(6) 2016, THE PATIENT EXPERIENCED HYPACTIVITY OF THE LUNG, BUT NO CAUSE COULD BE DETERMINED. ON (B)(6) 2016, VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WAS PERFORMED BECAUSE THE HYPACTIVITY HAD NOT SUBSIDED. DURING THE VATS, A PERFORATION OF THE TRACHEA WAS FOUND. THE DELAYED PERFORATION WAS APPROXIMATELY 1 TO 2 MM IN SIZE. THEREFORE, FASCIA WAS USED TO REPAIR THE SMALL HOLE. NOTE: THE ERBE ESU AND 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
    833068 ERBE BICLAMP LAPAROSCOPIC INSTRUMENTS BICLAMP FORCEPS GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R