BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 2932456 · Received January 24, 2013

    Report

    Report Number
    1044475-2013-00014
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: DURING A SAMPLE TRIAL, UPON REMOVAL OF THE SUTURE PASSER OUT OF THE DEVICE, IT WAS APPARENT THAT THE TIP OF THE SUTURE PASSER HAD BROKEN OFF. THE TIP OF THE DEVICE WAS VISUALIZED WITH THE CAMERA LYING ON THE BOWEL. THE SURGEON USED A LAPAROSCOPIC NEEDLE GRASPER TO REMOVE THE TIP. THIS WAS DONE WITHOUT INCIDENT. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34669 WECK ENDO FASCIAL CLOSURE SYSTEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX EFX038086

    Patients

    Seq Age Sex Outcome Treatment
    1