BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2243553 · Received August 26, 2011

    Report

    Report Number
    9610617-2011-00036
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 26, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUTERY PIN BROKE OFF FROM 2 HANDLES (BOTH WITH SAME PRODUCTION LOT AND ABOUT ONE YEAR OLD) DURING THIS PROCEDURE; THE HOSPITAL DID NOT HAVE REPLACEMENTS SO THEY ABORTED THE CASE. EVAL OF INSTRUMENTS CONFIRMED THAT THE HIGH FREQUENCY PIN ON THE 26284HM BIPOLAR RING HANDLES BROKE OFF INSIDE THE 26176LA CORD.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A PITUITARY TUMOR RESECTION, WHEN THE CAUTERY PIN BROKE OFF INSIDE THE CORD CONNECTOR FROM THE HANDLE AND WOULD NO LONGER FUNCTION. PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE FOLLOWING DAY, AND IT WAS COMPLETED WITH NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ BIPOLAR HANDLE GEI KARL STORZ GMBH & CO. KG 26284HM NZ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other