BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT ADAPTOR, UNIVERSAL

    MDR report key: 1942049 · Received November 9, 2010

    Report

    Report Number
    3003898360-2010-00470
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE VALVE SEAL WAS DISASSOCIATED FROM THE TROCAR AND FELL DURING AN INSERTION TEST OF THE LAPAROSCOPIC INSTRUMENT. THIS OCCURRED DURING TRAINING AND WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT ADAPTOR, UNIVERSAL ADAPTOR GCJ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA