BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    011168-10 ELEKTRODE, BIPOLAR

    MDR report key: 15748779 · Received November 7, 2022

    Report

    Report Number
    2020550-2022-00298
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 12, 2022
    Report Date
    November 7, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    UDI-DI
    04048551411087
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 PRODUCT IN QUESTION IS NOT SOLD INT HE U.S. HOWEVER, A SIMILAR DEVICE IS SOLD IN THE UNITED STATES AND THEREFORE, THIS INCIDNT WILL REQUIRE A MEDWATCH REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH BIPOLAR LOOPS. 3 HAVE BROKEN INSIDE A PATIENT. THE SURGEON SAID IT WAS GETTING CAUGHT ON THE INNER SHEATH OF THE RESECTOSCOPE BUT WAS BREAKING WITHOUT ANY FORCE. PRODUCT WAS INSIDE PATIENT DURING SURGERY BUT HAD BEEN RETRIEVED BY CONSULTANT. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227922 011168-10 ELEKTRODE, BIPOLAR ELEKTRODE, BIPOLAR FAS KARL STORZ SE & CO. KG 011168-01 04048551411087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown