BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 3900271 · Received May 1, 2014

    Report

    Report Number
    3003898360-2014-00304
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE AVAILABLE FOR INVESTIGATION. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED AND IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. PER DHR, THE PRODUCT VISISTAT 35W 6/BOX, LOT #01A1400291 WAS MANUFACTURED ON 01/16/2014. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER, THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED PROBLEM: IT WAS REPORTED THAT THE STAPLERS ARE NOT CLOSING, EASILY REMOVED BY FINGERS. NO PATIENT CONSEQUENCES. PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262331 VISISTAT 35W 6/BOX STAPLER GAG TELEFLEX MEDICAL 01A1400291

    Patients

    Seq Age Sex Outcome Treatment
    1