BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAW GRASP/EXTR FCOS 2X3T 10MM

    MDR report key: 3901641 · Received May 6, 2014

    Report

    Report Number
    2523190-2014-00023
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 11, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GCJ
    PMA / PMN Number
    K931928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    AFTER LAPAROSCOPIC OPERATION, THE CUSTOMER FOUND THE JAW WAS BROKEN. THEY CONFIRMED THAT NO BROKEN PARTS WERE LEFT INSIDE THE PATIENT'S BODY. ON (B)(6) 2014 DEALER REPORTS DOCTOR WAS PERFORMING A UTERINE MYOMECTOMY. WHEN THE FORCEPS WAS INSERTED INSIDE THE PATIENT'S BODY THE DOCTOR TRIED TO HOLD A TISSUE WITH IT AND OPENED THE JAWS, THEN THE JAW CAME LOOSE. THE FORCEPS JAW BROKE BEFORE TOUCHING THE PATIENT'S BODY/TISSUE. THE DOCTOR INSPECTED THE PATIENT'S BODY BY DETAILED VISUAL INSPECTION AND IS SURE THAT NO LOOSE PARTS REMAINED IN PATIENT'S BODY. THEY DID NOT USE AN X-RAY, SINCE THE INCIDENT HAPPENED UNDER THE DOCTOR'S VISUAL FIELD, AND THEY SAW NO LOOSE PARTS DROPPING INSIDE THE PATIENT'S BODY. JUST TO BE CERTAIN, THE DOCTOR INSPECTED THE PATIENT'S BODY IN DETAIL AND FOUND NO LOOSE PARTS. NO HARM OCCURED TO THE PATIENT. THE PATIENT LEFT THE HOSPITAL AS SCHEDULED IN GOOD CONDITION. THE INCIDENT OCCURRED DURING (B)(6). HOSPITAL REPORTED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271775 CLAW GRASP/EXTR FCOS 2X3T 10MM NONE GCJ INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1