BEUDAMED
    FDA Adverse Event Summary report: N

    5MMX45CM 22MM DIRECT DRIVE DISPOSABLE GRASPER

    MDR report key: 2875340 · Received December 12, 2012

    Report

    Report Number
    2027111-2012-00384
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    SINGLE SITE GASTRECTOMY - "DURING THE PROCEDURE, THE SURGEON UTILIZED THE GRASPERS LOCKING MECHANISM ON A PORTION OF THE PT'S STOMACH. WHEN HE TRIED TO UNLOCK THE GRASPERS, THEY WOULD NOT UNLOCK. AFTER MULTIPLE ATTEMPTS, HE WAS ABLE TO UNLOCK THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MMX45CM 22MM DIRECT DRIVE DISPOSABLE GRASPER NONE GCJ APPLIED MEDICAL C4140

    Patients

    Seq Age Sex Outcome Treatment
    1