BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUCKER/MESSROGHLI SUPRALOOP

    MDR report key: 14643315 · Received June 9, 2022

    Report

    Report Number
    9610617-2022-00080
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 9, 2022
    Report Date
    November 4, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    KNF
    UDI-DI
    04048551393086
    PMA / PMN Number
    K944793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RETURNED, HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    PER EVALUATION FROM KST/MFR. "BASED ON THE INSPECTION OF THE INSTRUMENT, THE MOST PROBABLE ROOT CAUSE IS THAT THE CUSTOMER OPERATED THE DEVICE INCORRECTLY. PROBABLY TOO MUCH FORCE WAS APPLIED TO THE LOOP WITHOUT ACTIVATING THE HF CURRENT, MOREOVER, THE CURRENT WAS TOO HIGH, WHICH LED TO OVERHEATING/DAMAGE TO THE INSTRUMENT WHICH HAS BLACK DISCOLORATIONS AT THE BREAKAGE POINTS."

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY WITH BSO, THE LOOP SNAPPED RATHER THAN CUTTING WHEN CAUTERY PEDAL WAS DEPLOYED. THE SURGEON COMPLETED THE CASE WITH ANOTHER SMALL LOOP, WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892629 BRUCKER/MESSROGHLI SUPRALOOP SPARE SUPRA LOOP STERILE PACKAGE OF 6 KNF KARL STORZ SE & CO. KG 26183MC-S UO07 04048551393086

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other