BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOCATH FORCEPS

    MDR report key: 3252 · Received January 26, 1993

    Report

    Report Number
    3252
    Event Type
    Malfunction
    Date Received
    January 26, 1993
    Date of Event
    October 2, 1992
    Report Date
    October 20, 1992
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    HCZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE END OF THE JEW OF THE FORCEPS BROKE OFF IN PATIENTS 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLANGIOCATH FORCEPS HCZ OLYMPUS CORPORATION N-7-907-05

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other