BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGULATION & DISSECTION ELECTRODE

    MDR report key: 17127379 · Received June 14, 2023

    Report

    Report Number
    9610617-2023-00887
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    October 9, 2020
    Report Date
    June 7, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    KNF
    PMA / PMN Number
    K944862
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA: 20-0074 CORRECTIVE ACTION 6. THE DEVICE WAS EXERTED TOO MUCH FORCE CAUSE IT TO BEND THEN BREAK. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT. INVESTIGATION REVEALED THAT THE DISTAL TIP WAS BROKEN OFF AND THE TIP WAS HEAVILY BENT. NO SIGNS OF CORROSION WERE FOUND AT THE BROKEN AREA OF THE AFFECTED DEVICE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE L-HOOK TIP BROKEN AND DROPPED OFF IN PATIENT BODY DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821701 COAGULATION & DISSECTION ELECTRODE COAGULATION & DISSECTION ELECTRODE KNF KARL STORZ SE & CO. KG 37370DL UR01 / QO02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other