BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MMX32CM, A-TRAC GRASPER/5X20MM, A-TRAC INSERT

    MDR report key: 276024 · Received May 1, 2000

    Report

    Report Number
    2027111-2000-00004
    Event Type
    Other
    Date Received
    May 1, 2000
    Date of Event
    April 3, 2000
    Report Date
    May 1, 2000
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. CHOLECYSTECTOMY PROCEDURE, ONE OF THE C4103, A-TRAC GRASPER INSERTS COULD NOT BE LOCATED. THE PT WAS SEARCHED INTERNALLY AND THE INSERT COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED AND THE INSERT COULD NOT BE LOCATED INTERNALLY. THE REMAINING INSERT OF THE PAIR WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MMX32CM, A-TRAC GRASPER/5X20MM, A-TRAC INSERT A-TRAC GRASPER/A-TRAC INSERT HET APPLIED MEDICAL RESOURCES C5206 00A514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other