BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 30151 · Received December 22, 1995

    Report

    Report Number
    30151
    Event Type
    Malfunction
    Date Received
    December 22, 1995
    Date of Event
    May 8, 1995
    Report Date
    December 18, 1995
    Manufacturer
    STRYKER CORP.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPY IN PROGRESS WHEN PHYSICIAN NOTED METAL SHAVING BEING LEFT IN KNEE BY 5.0 ANGLED BLADE. KNEE FLUSHED. SURGERY CONTINUED WITH NEW BLADE.DEVICE 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY 5.0 MM ANGLED AGGRESSIVE MENISCUS HRX STRYKER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other