BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDON STRIPPER, 7 MM

    MDR report key: 16108294 · Received January 5, 2023

    Report

    Report Number
    2020550-2023-00006
    Event Type
    Injury
    Date Received
    January 5, 2023
    Report Date
    January 5, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4). KARL STORZ SE & CO. KG WAS INFORMED THAT THIS DEVICE WAS USED FOR A FURTHER SURGERY. THIS CASE WILL BE HANDLED/REPORTED AS CASE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TENDON STRIPPER BECAME WORN AFTER APPROX. 50 USES. THIS WORN INSTRUMENT WAS USED FOR SURGERY, THAT TORE 2 TENDONS. THERE WAS A PROLONGATION OF APPROX. 1H AND A SECOND SURGEON WAS NEEDED. NO FURTHER INFORMATION REGARDING THE STATE OF HEALTH IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644876 TENDON STRIPPER, 7 MM TENDON STRIPPER LXH KARL STORZ SE & CO. KG 28729AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention