BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT FIXED HEAD SKIN STAPLER, 35W

    MDR report key: 2211138 · Received August 8, 2011

    Report

    Report Number
    3003898360-2011-00341
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 27, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE HISTORY RECORD REVIEW. RESULTS - THE DHR REVIEW SHOWED THAT NO SIMILAR ISSUES WERE FOUND DURING THE MANUFACTURING OR PACKAGE PROCESS OF THIS LOT. CONCLUSIONS - CAPA #(B)(4) WAS OPENED TO ADDRESS THE ISSUE OF STAPLES JAMMING. IF ADD'L INFO IS RECEIVED THAT CHANGES THE CONCLUSION OF THE INVESTIGATION, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE STAPLER JAMMED DURING A CAESAREAN SECTION, BUT THERE WAS NO HARM CAUSED TO THE PT. ANOTHER VISISTAT STAPLER WAS USED TO CONTINUE THE PROCEDURE. "IT APPEARS THAT THE STAPLER JAMMED DUE TO THE TRIGGER PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT FIXED HEAD SKIN STAPLER, 35W SKIN STAPLER GDT TELEFLEX MEDICAL NA 01F1000366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK