BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 3252525 · Received July 24, 2013

    Report

    Report Number
    1044475-2013-00109
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: AT THE END OF A LAPAROSCOPIC GYN PROCEDURE, THE SURGICAL ASSISTANT REMOVED THE TROCAR AND TRIED TO INSERT THE EFX DEVICE INTO THE DEFECT. THE SURGICAL ASSISTANT HAD A DIFFICULT TIME PLACING THE DEVICE INTO THE DEFECT. AS HE WAS PUSHING DOWN ON THE DEVICE TO PASS IT THROUGH THE FASCIAL DEFECT, HE HEARD A CRACK SOUND. HE IMMEDIATELY REMOVED THE EFX AND NOTICED THAT 1 WING BROKE OFF INTO THE PT'S SUBCUTANEOUS SPACE. UPON FURTHER INVESTIGATION, HE ALSO NOTICED THAT THE GRAY HINGE THAT HOLDS THE WINGS IN PLACE HAD ALSO BROKE. BOTH PIECES WERE REMOVED FROM THE SUBCUTANEOUS FAR SPACE. A NEW DEVICE WAS THEN USED SUCCESSFULLY TO CLOSE THE FASCIAL DEFECT. PLEASE NOTE THAT THE PT HAD A VERY THICK ABDOMINAL WALL WHICH SURGICAL ASSISTANT NOTED THAT THE THICKNESS MADE THE PASSAGE OF THE EFX DEVICE MORE DIFFICULT. NO REPORTED PT INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347005 WECK ENDO FASCIAL CLOSURE SYSTEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX EF038249

    Patients

    Seq Age Sex Outcome Treatment
    1