BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR HIGH FREQUENCY CORD, 400 CM

    MDR report key: 20412526 · Received October 9, 2024

    Report

    Report Number
    9610617-2024-00371
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Report Date
    December 12, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GEI
    UDI-DI
    04048551388778
    PMA / PMN Number
    K221893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION D10. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONLY THE BIPOLAR HIGH FREQUENCY CORD (ARTICLE UH801) WAS RETURNED FOR THE INVESTIGATION. THE EXAMINATION OF THE CORD REVEALED SIGNIFICANT DISCOLORATION AND SEVERE WEAR AT THE CONNECTOR, ALONG WITH A DEVELOPING HOLE ON THE SURFACE. THESE FINDINGS SUGGEST THAT THE CORD WAS SUBJECTED TO HEAVY USAGE AND LIKELY EXCEEDED ITS EXPECTED SERVICE LIFE OF 20 CYCLES. ALTHOUGH THE DEVICES UH400 (AUTOCON II), 011168-10 (BIPOLAR ELECTRODE) AND 27050SL (RESECTOSCOPE SHEATH) WERE INVOLVED IN THE EVENT, THEY WERE NOT THE CAUSE. THE CORD EXPERIENCED A BURNOUT, AND DUE TO THE EXTENT OF THE WEAR, IT SHOULD NOT HAVE BEEN USED. THE CORRESPONDING IFU SPECIFIES THAT ALL EQUIPMENT AND COMPONENTS MUST BE INSPECTED TO ENSURE THEY ARE IN PROPER WORKING CONDITION BEFORE USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 AND D10 THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED LOT NUMBER AND CONCOMITANT MEDICAL PRODUCTS UH400 SERIAL NUMBER (B)(6) AND RESECTOSCOPE (ARTICLE NUMBER CURRENTLY UNKNOWN), THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BURNED CABLE UH801. USING AUTOCON AND RESECTOSCOPE AND 011168-10. CABLE WAS BURNED ON TOP OF THE PART THAT CONNECTS WITH THE ELECTRODE. NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958138 BIPOLAR HIGH FREQUENCY CORD, 400 CM BIPOLAR HIGH FREQUENCY CORD GEI KARL STORZ SE & CO. KG UH801 PM01 04048551388778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 011168-10 SERIAL: UNKNOWN| ARTICLE: 27050SL, LOT: RS03| MATERIAL: 011168-10| MATERIAL: 27050SL| MATERIAL: UH400| MATERIAL: UH400 SN: (B)(6) - RESECTOSCOPE