BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT FIXED HEAD SKIN STAPLER, 35R

    MDR report key: 2192943 · Received July 20, 2011

    Report

    Report Number
    3003898360-2011-00316
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED. RESULTS - THE DHR REVIEW SHOWED THAT NO SIMILAR ISSUES WERE FOUND DURING THE MFG OR PACKAGING PROCESSES OF THIS LOT. CONCLUSIONS: (B)(4) WAS OPENED TO ADDRESS THE ISSUE OF STAPLES JAMMING. IF ADDITIONAL 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: "THE STAPLER DOES NOT DELIVER THE STAPLES. THEY SUCCESSFULLY USED ANOTHER STAPLER, NO CONSEQUENCES FOR THE PT. DEFECT WAS DISCOVERED DURING A CAESARIAN SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT FIXED HEAD SKIN STAPLER, 35R SKIN STAPLER GDT TELEFLEX MEDICAL 01H1000293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK