BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING LOOP, BIPOLAR

    MDR report key: 15690452 · Received October 28, 2022

    Report

    Report Number
    9610617-2022-00295
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    September 27, 2022
    Report Date
    October 28, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    UDI-DI
    04048551393864
    PMA / PMN Number
    K061541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE EVALUATION FINDINGS THE LOOP WAS BROKEN OFF AND NOT RETURNED. THE ORANGE INSULATION WAS MELTED AT THE BREAK AND IS BENT IN THE MIDDLE. ADDITIONALLY, THERE IS BLACK RESIDUE ON THE ORANGE AND YELLOW INSULATION. THE IFU 97000002USCA 02-2019, STATES " THE PRODUCT SHOULD NOT BE MANIPULATED OR BENT. OVERLOADING THE INSTRUMENT BY EXERTING TOO MUCH FORCE MAY CAUSE THE MEDICAL DEVICE TO BREAK, BEND, AND MALFUNCTION, AND CONSEQUENTLY INJURE THE PATIENT OR USER. DO NOT OVERLOAD THE INSTRUMENTS. DO NOT BEND BENT INSTRUMENTS BACK TO THEIR ORIGINAL POSITIONS".

    Description of Event or Problem · 0

    THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). PER SE ROBERT SAPP THE DOCTOR USED ONE OF THE ELECTRODES 27040GP130-S DOING A TURP PROCEDURE. THE WIRE LOOP PORTION BROKE OFF IN THE PATIENT. THEY SEARCHED FOR THE LOOP AND WERE UNABLE TO FIND THE LOOP. PER SE THE LOOP WAS NOT LOCATED DURING X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692382 CUTTING LOOP, BIPOLAR BIPOLAR SINGLE USE CUTTING LOOP FAS KARL STORZ SE & CO. KG 27040GP130-S RN11 04048551393864

    Patients

    Seq Age Sex Outcome Treatment
    1 Male