BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2971190 · Received February 4, 2013

    Report

    Report Number
    9610617-2013-00002
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    November 28, 2012
    Report Date
    February 4, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT RETURN CABLE TO KARL STORZ; THEY DID SENT IT TO BARETICH ENGINEERING FOR ANALYSIS. HERE ARE THE RESULTS OF THEIR INVESTIGATION: CABLE IN GOOD CONDITION. THERE IS A NOTICEABLE HOLE IN THE OUTER COVER OF THE CABLE APPROX 75 CM FROM THE DISTAL INSTRUMENT END. APPEARANCE SUGGESTS THAT CORD MAY HAVE BEEN PINCHED CAUSING A SMALL PIECE OF INSULATION TO TEAR AWAY. THERE WAS DISCOLORATION AROUND THE INSULATION BREACH WHICH IS A RESULT OF THE ARCING. RECOMMEND THAT HOSPITAL REVIEW HANDLING AND CLEANING PROCESSES FOR THIS PRODUCT.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING PROSTATECTOMY WHEN HE NOTED A SPARK MIDWAY ON THE HIGH FREQUENCY CABLE. THEY CHECKED PT AND FOUND A 2 MM MINOR BURN ON THE HIP WHERE CABLE HAD BEEN LAID. HOSPITAL APPLIED BACITRACIN; PT HEALING WELL. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47219 KARL STORZ HIGH FREQUENCY CORD KNS KARL STORZ GMBH & CO. KG 26006M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other