BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W

    MDR report key: 4928520 · Received July 21, 2015

    Report

    Report Number
    3003898360-2015-00495
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 18, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W 6/BOX, LOT NUMBER 73L1400336 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: DURING PARATHYROID SURGERY THE STAPLER DID NOT WORK IT WAS STUCK. A SECOND STAPLER FROM THE SAME LOT NUMBER WAS USED BUT THE PROBLEM OCCURRED AGAIN. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472807 VISISTAT 35W STAPLER GAG TELEFLEX MEDICAL 73L1400336

    Patients

    Seq Age Sex Outcome Treatment
    1