BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRALOOP REPLACEMENT SLING

    MDR report key: 17127369 · Received June 14, 2023

    Report

    Report Number
    9610617-2023-00889
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    July 9, 2019
    Report Date
    June 12, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    KNF
    PMA / PMN Number
    K944793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ROOT CAUSE MOST LIKELY IS TOO HIGH FORCE APPLICATION DURING PULLING THE LOOP BACK INTO THE OUTER SHEATH. DURING THE INVESTIGATION NO INDICATIONS FOR A MATERIAL OR MANUFACTURING RELATED ISSUE WERE FOUND. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)..

    Description of Event or Problem · 0

    THE ISOLATION OF THE RETURNED LOOP WAS FOUND TO BE DAMAGED. THE ISOLATION SHOWS PEEL OFF ON BOTH SIDES. FURTHERMORE THERE IS A VISIBLE CUT ON THE ISOLATION. THE WIRE IS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875082 SUPRALOOP REPLACEMENT SLING SUPRALOOP HANDLE KNF KARL STORZ SE & CO. KG 26183MC UR08

    Patients

    Seq Age Sex Outcome Treatment
    1 Female