BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 81289 · Received April 1, 1997

    Report

    Report Number
    81289
    Event Type
    Malfunction
    Date Received
    April 1, 1997
    Date of Event
    February 10, 1997
    Report Date
    February 20, 1997
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED FOR A LAPAROSCOPIC CHOLECYSTECTOMY WITH OPERATIVE CHOLANGIOGRAM AS AN OUTPATIENT. AFTER FINISHING THE CHOLANGIOGRAM, THE INSTRUMENT WAS REINSERTED INTO THE ABDOMINAL CAVITY AT THE MOST LATERAL PORT. THE ASSISTANT SURGEON GRASPED ON THE VIDEO SCOPE CAMERA, THE GRASPER SEEMED TO BE MALFUNCTIONING, SO IT WAS WITHDRAWN. IT WAS MISSING A LOCKING SCREW ABOUT 2MM IN LENGTH. THE SCREW WAS UNABLE TO BE LOCATED. THE LAPAROSCOPIC SURGERY PROCEEDED AND THE PT WAS DISCHARGED IN STABLE CONDITION. THE 2MM INTERLOCK SCREW REMAINS IN THE PERITONEAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ENDOSCOPIC GRASPER GCJ CABOT MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR