BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLOW CROAK

    MDR report key: 27653 · Received October 2, 1995

    Report

    Report Number
    27653
    Event Type
    Injury
    Date Received
    October 2, 1995
    Date of Event
    May 10, 1995
    Report Date
    May 12, 1995
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A LIVER BIOPSY THROUGH THE LAPAROSCOPE WHEN THE BIOPSY FORCEPS TIP BROKE OFF INSIDE THE PTS ABDOMEN.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLOW CROAK BIOPSY FORCEPS KNW MARLOW SURGICAL TECHNOLOGIES, INC. MP757

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention