BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE STRUCTURAL BALLOON

    MDR report key: 9811235 · Received March 10, 2020

    Report

    Report Number
    9811235
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 22, 2020
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON DID NOT INSUFFLATE DURING PROCEDURE. ANOTHER BALLOON TROCAR WAS USED TO INSUFFLATE THE ABDOMEN DURING THE LAPAROSCOPIC CASE. (01) 10884521081086, (17) 220831, (B)(4), LOT: P9J1077Y, EXP: 08-31-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273186 AUTO SUTURE STRUCTURAL BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN OMS-T10SB P9J1077Y

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA