BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT FIXED HEAD SKIN STAPLER, 35R

    MDR report key: 2121942 · Received May 24, 2011

    Report

    Report Number
    3003898360-2011-00250
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 10, 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

    EVAL: METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS - NO SIMILAR DEFECT WAS REPORTED DURING THE MFG OR PACKAGE PROCESSES OF THIS LOT. CONCLUSIONS: A CAPA WAS OPENED TO ADDRESS THIS ISSUE (B)(4). IF ADDITIONAL INFO IS RECEIVED THAT AFFECTS THE CONCLUSION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "STAPLE JAMMED/THEY COULD USE ONLY ONE OR TWO STAPLES. DEFECT WAS DISCOVERED DURING AN UNK OPERATION. NO MEDICAL INTERVENTION WAS NECESSARY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT FIXED HEAD SKIN STAPLER, 35R SKIN STAPLER GDT TELEFLEX MEDICAL 01B1000403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK