BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATOME SPHINCTEROTOME

    MDR report key: 74 · Received February 25, 1992

    Report

    Report Number
    74
    Event Type
    Injury
    Date Received
    February 25, 1992
    Date of Event
    January 13, 1992
    Report Date
    January 30, 1992
    Manufacturer
    MICROVASIVE-BOSTION SCIENETIFIC CORPORATION
    Product Code
    HQO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    COAGULATION SETTING OF CAUTERY SET AT 75. PATIENT SUFFERED PERFORATION OF BILE DUCT AND WAS TAKEN TO SURGERY FOR REPAIR THE NEXT DAYDEVICE 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 NOT USED AS LABELED/INDENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: INVALID DATA, DEVICE FAILED JUST PRIOR TO USE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATOME SPHINCTEROTOME N/A HQO MICROVASIVE-BOSTION SCIENETIFIC CORPORATION N/A 48690

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention