BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ELECTRODE 24/26 FR

    MDR report key: 15519149 · Received September 30, 2022

    Report

    Report Number
    9610617-2022-00274
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 1, 2022
    Report Date
    June 12, 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
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE PRODUCT FOUND THE DISTAL LOOP IS BROKEN FROM ONE SIDE OF THE HOUSING'S SHAFT. ADDITIONALLY, THE INSULATION AT THE PROXIMAL END HAS BLACK RESIDUE AND THE SHAFT IS BENT. A COMPLAINT REVIEW FOR SIMILAR ARTICLES FOR THE TIMEFRAME 20-JUL-2020 - 23-SEP-2022 WAS PERFORMED. SIMILAR COMPLAINTS COULD BE FOUND. IN ONE OF THESE CASES, AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. CONSEQUENTLY, IT IS REQUIRED TO A REPORT TO FDA.

    Additional Manufacturer Narrative · 0

    FOLLOW UP DATES FROM 11/9/2022 - 12/14/2022 WENT UNANSWERED BY REP/FACILITY FOR EXCHANGE APPROVAL. THE PRODUCT WAS SENT TO KST/MFR. TO COMPLETE EVALUATION ON 01/03/2023. ON 01/17/2023 RECEIVED EMAIL FROM KST/MFR. STATING THAT THE PRODUCT HAD NOT BEEN RECEIVED AND "APPARENT CAUSE, BASED ON THE CUSTOMER'S DESCRIPTION, IS A MECHANICAL OVERLOAD DUE TO EXCESSIVE FORCE. KST/MFR. APPROVED A CREDIT NOTE ON 04/17/2023 STATING " WARRANTY CLAIM FOR THE RETURNED ARTICLE IS JUSTIFIED. REPLACEMENT ARTICLE SENT TO FACILITY ON 05/04/2023.

    Description of Event or Problem · 0

    THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). ACCORDING TO THE INFORMATION RECEIVED A BIPOLAR ELECTRODE BROKE DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT, USER OR THIRD DUE TO THIS MALFUNCTION. ALL PARTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384568 BIPOLAR ELECTRODE 24/26 FR CUTTING LOOP FAS KARL STORZ SE & CO. KG 27040GP1-S ON05 04048551393482

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly