BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, BIPOLAR

    MDR report key: 18066792 · Received November 3, 2023

    Report

    Report Number
    9610617-2023-00347
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 18, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED ON 2023-10-27.THE INVESTIGATION OF THE PRODUCT WAS COMPLETED ON 2023-12-06. DURING THE EVALUATION OF THE PRODUCT IT WAS FOUND THAT THE CUTTING LOOP IS BROKEN OF ON THE POWER SUPPLYING SIDE. THE INSULATION SHOWS A MOLTEN AREA THAT INDICATES A USE FOR SOME TIME. DUE TO THE POSITION OF THE BREAK (LONGEST LEVER) IT IS MOST LIKELY, THAT THE LOOP GOT MECHANICALLY OVERLOADED DURING USE - E. G. BY TISSUE CONTACT WITHOUT ACTIVATED HF CURRENT. DEVICE HISTORY RECORDS (DHR), RECENT PRODUCT OR PROCESS CHANGES WERE REVIEWED. ACCORDING TO THE RESULTS OF THE DEVICE HISTORY REVIEW, THERE WAS NO INDICATION FOR A MANUFACTURING FAILURE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIPOLAR TURP CASE ONE OF THE LOOPS BROKE INTO TWO PIECES. ONE OF THE PIECES FELL INSIDE THE PATIENT AND WAS RETRIEVED BY THE SURGEON. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. AS A PROLONGATION OF 3 HOURS WAS REPORTED, THE CASE DEEMED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207012 ELECTRODE, BIPOLAR ELECTRODE, BIPOLAR FAS KARL STORZ SE & CO. KG 011160-10 844290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown