BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM LAPAROSCOPIC IRRIGATION TUBING

    MDR report key: 5910107 · Received August 24, 2016

    Report

    Report Number
    MW5064376
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 24, 2016
    Manufacturer
    BARD-DAVOL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE X-STREAM LAPAROSCOPIC IRRIGATION TUBING SET REF: (B)(4) (BARD-DAVOL, INC) FAILED TO WORK. INSTRUMENT EXCHANGED AND FAILED TO WORK AGAIN. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551267 X-STREAM LAPAROSCOPIC IRRIGATION TUBING X-STREAM LAPAROSCOPIC IRRIGATION TUBING GCJ BARD-DAVOL, INC.
    551268 X-STREAM LAPAROSCOPIC IRRIGATION TUBING X-STREAM LAPAROSCOPIC IRRIGATION TUBING GCJ BARD-DAVOL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR