BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM

    MDR report key: 17152301 · Received June 19, 2023

    Report

    Report Number
    9610617-2023-00714
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    April 19, 2019
    Report Date
    June 19, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K951625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST
    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 EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ((B)(4)). DUE TO THE DAMAGES VISIBLE ON THE RETURNED DEVICE THE ROOT CAUSE MOST LIKELY IS A HIGH FORCE IMPACT WHICH CAUSED THE INSERT TO BLAST OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A "NEEDLE HOLDER". ACCORDING TO THE INFORMATION RECEIVED, THE NEEDLE HOLDER BROKE SHORTLY AFTER IT WAS INTRODUCED IN THE ABDOMEN. THE BROKEN PART WAS COMPLETELY RECOVERED. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092848 ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM SUTURING NEEDLE HOLDER, REUSABLE GCJ KARL STORZ SE & CO. KG 26167FNS YR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown