BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ELECTRODE 24/26 FR

    MDR report key: 16768903 · Received April 19, 2023

    Report

    Report Number
    9610617-2023-00083
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    February 28, 2023
    Report Date
    August 4, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    UDI-DI
    04048551393482
    PMA / PMN Number
    K882270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KST/MFR. HAS PROVIDED THE COMPLAINT PRODUCT INVESTIGATION PLAN AND REPORT WHICH IS BASED ON THE NON RETURN OF PRODUCT. REPORT CONCLUSION ROOT CAUSE IS ACCORDING TO THE CUSTOMER, THE CUTTING LOOP WAS PULLED OUT IN THE DISTAL AREA. THE REASON FOR THIS COULD BE, FOR EXAMPLE, EXCESSIVE TENSILE FORCE ON THE LOOP WITHOUT HAVING ACTIVATED THE HF CURRENT. HOWEVER, SINCE THE ARTICLE WAS NOT SENT IN FOR EXAMINATION, NO MORE PRECISE STATEMENT CAN BE MADE ON THIS. THE IFU POINTS OUT THE CORRECT HANDLING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT HAS BEEN DISCARDED BY THE FACILITY. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION WE RECEIVED, THE ELECTRODE ITEM 27040GP1-S BIPOLAR CUTTING LOOP WAS MISSING FROM THE ELECTRODE. THE LOOP WAS FOUND INSIDE THE PATIENT'S BLADDER, IT WAS RETRIEVED AND THE TURP PROCEDURE COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686376 BIPOLAR ELECTRODE 24/26 FR CUTTING LOOP FAS KARL STORZ SE & CO. KG 27040GP1-S 37KB3555 04048551393482

    Patients

    Seq Age Sex Outcome Treatment
    1 Male