BEUDAMED
    FDA Adverse Event Summary report: N

    MICRO TUNGSTEN GRIP NEEDLE HOLDER

    MDR report key: 26862 · Received August 25, 1995

    Report

    Report Number
    1416557-1995-00005
    Date Received
    August 25, 1995
    Report Date
    August 24, 1995
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Product Code
    GDH
    Report Source
    Distributor report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE DURING A SURGICAL PROCEDURE. NO OTHER INFO WAS REPORTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO TUNGSTEN GRIP NEEDLE HOLDER NEEDLE HOLDER GDH T. KOROS SURGICAL INSTRUMENTS CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data