BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR CLOSURE-SUTURE GRASPER

    MDR report key: 3943273 · Received July 9, 2014

    Report

    Report Number
    3943273
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 9, 2014
    Manufacturer
    PROGRESSIVE MEDICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE CLOSING THE TROCAR INCISION THE TROCAR CLOSURE SUTURE GRASPER WAS DEPLOYED. WHEN OPENED, THE GRASPER PORTION FLIPPED UP AT A 120 DEGREE ANGLE. THE DOCTOR WAS UNABLE TO PLACE THE GRASPER IN THE CORRECT POSITION FOR CLOSURE. THE DOCTOR HAD TO USE ANOTHER INSTRUMENT TO BREAK THE GRASPER WIRE. NO HARM TO PATIENT AND ONLY A FEW MINUTES OF EXTENDED TIME IN SURGERY WHILE NEW INSTRUMENT OBTAINED.MANUFACTURER RESPONSE FOR TROCAR CLOSURE SUTURE GRASPER, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NONE AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399136 TROCAR CLOSURE-SUTURE GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ PROGRESSIVE MEDICAL INC. 15 CM LENGTH 14 GAGE *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR