BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-POLAR ELECTRODE

    MDR report key: 16040231 · Received December 22, 2022

    Report

    Report Number
    1221826-2022-00342
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    September 29, 2022
    Report Date
    August 14, 2023
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FAS
    UDI-DI
    04048551411087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DUE TO THE HEAVY BENDING, IT IS ASSUMED THAT THE ELECTRODE GOT EXPOSED TO EXCESSIVE FORCE DURING THE APPLICATION. THE FORCE NEEDED TO CREATE THIS BENDING IS NOT REQUIRED DURING APPLICATION AS INTENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 12/15/2022, KSEC RECEIVED INQUIRY FROM HEALTH CANADA REQUESTING THE ADDITIONAL INFORMATION BELOW: THE INVESTIGATION IS STILL ONGOING. WE WILL PROVIDE YOU THIS INFORMATION. 1 SIMILAR COMPLAINT AND OR INJURIES REPORTED WITH THIS DEVICE IN CANADA IN 2020 AND 2 REPORTED INTERNATIONALLY IN 2021. AS THE INVESTIGATION IS ONGOING, THE ROOT CAUSE CAN NOT BE ESTABLISHED. 1/12/2023: INVESTIGATION IS BEING CARRIED OUT BY MANUFACTURER KST. NEW ANTICIPATED DATE FOR THE FINAL REPORT WILL BE END OF APRIL. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE LOOP OF THE BIPOLAR ELECTRODE BROKE OFF INSIDE THE PATIENT DURING A TRANSURETHRAL RESECTION OF A BLADDER TUMOR BUT COULD BE RETRIEVED. NO HARM TO THE PATIENT, THE USER OR THIRD REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738916 BI-POLAR ELECTRODE BI-POLAR ELECTRODE FAS KARL STORZ ENDOSCOPY-AMERICA, INC. 011165-10 837970 04048551411087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown