BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER FIBER

    MDR report key: 3013 · Received September 2, 1992

    Report

    Report Number
    3013
    Event Type
    Malfunction
    Date Received
    September 2, 1992
    Date of Event
    January 29, 1992
    Report Date
    February 13, 1992
    Manufacturer
    SURGIMEDICS
    Product Code
    LWX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEVICES - YAG LASER, LASER FIBERDURING AN ARTHOSCOPIC PROCEDURE, THE TIP OF A LASER FIBER BROKE OFF IN THE PATIENT'S KNEE. SEVERAL ATTEMPTS WERE MADE TO RETREIVE THE TIP, BUT EFFORTS WERE UNSUCCESSFUL. X-RAYS WERE TAKEN WITH NEGATIVE RESULTS. IT WAS DETERMINED THAT THE TIP IS POSSIBLY IN THE SOFT TISSUEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER FIBER LWX SURGIMEDICS N/A 080000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other