BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 3826870 · Received February 28, 2014

    Report

    Report Number
    1044475-2014-00038
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE FIRST PASS WAS SUCCESSFUL, BUT AFTER PASSING THE SECOND SUTURE TAIL, IT WAS NOTICED THAT THE TIP OF THE SUTURE PASSER FROM THE SUTURE NOTCH TO THE DISTAL TIP WAS MISSING. THE DOCTOR SCANNED THE OMENTUM BUT WAS UNABLE TO LOCATE THE SUTURE PASSER TIP. A SECOND EFX WAS USED TO COMPLETE THE CLOSURE. NO REPORTED PT INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124335 WECK ENDO FASCIAL CLOSURE SYSTEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX EF038478

    Patients

    Seq Age Sex Outcome Treatment
    1