BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 1737593 · Received June 22, 2010

    Report

    Report Number
    9610614-2010-00014
    Event Type
    Other
    Date Received
    June 22, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. (B)(6) ANALYZED THE INVOLVED CABLE AND FOUND THAT IT HAD A LOOSE CONTACT. THEY CONCLUDED THAT THE CABLE WAS DAMAGED BY EXCESSIVE FORCE (PULLING OR BENDING) [NOTE: THE CABLE WAS ALSO VERY OLD, 10+ YEARS.]. MOST LIKELY THE CABLE BREACH CAUSED THE ELECTRICAL SHOCK TO THE DOCTOR AND RESULTING ISSUES. 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 PT INCIDENT OCCURRED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE ESU WAS USED WITH A RICHARD WOLF RESECTOSCOPE [NOTE: A WOLF CABLE, TYPE 815.034 (LOT NUMBER 4/99) WAS ALSO USED.]. DURING THE PROCEDURE, THE PHYSICIAN WAS SHOCKED ELECTRICALLY AND ACOUSTICALLY, RESULTING IN THE SCOPE NOT BEING CONTROLLED. AS A RESULT, THE PT'S PROSTATE CAPSULE NEAR THE SPHINCTER WAS PERFORATED. NO FURTHER INFO WAS PROVIDED IN REGARDS TO THE PT'S INFO OR PROGNOSIS. NOTE: THE ESU WAS DISTRIBUTED BY OUR PARENT COMPANY (ERBE (B)(6)) TO A (B)(6) HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other