BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX MEDICAL TAUT 10/12M BALLOON

    MDR report key: 1258490 · Received December 1, 2008

    Report

    Report Number
    MW5009144
    Event Type
    Injury
    Date Received
    December 1, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 1, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON TROCAR TIP BROKE WHEN INSERTED INTO PATIENT FOR LAPAROSCOPIC PORT; PLASTIC PIECE WENT INTO PATIENT'S ABDOMEN. PIECES WERE RETRIEVED LAPAROSCOPICALLY PER DR MATTHEWS. DOCTOR STATED RETRIEVAL WAS NOT A BIG DEAL. BROKEN TROCAR WAS REPLACED AND INSTRUMENT FAILURE FORM FILLED OUT. TROCAR WAS A DISPOSABLE. TROCAR WAS EXAMINED TO DETERMINE ALL PIECES WERE RETRIEVED WAS NOT A BIG DEAL. BROKEN TROCAR WAS REPLACED AND INSTRUMENT FAILURE FORM FILLED OUT. TROCAR WAS A DISPOSABLE. TROCAR WAS EXAMINED TO DETERMINE ALL PIECES WERE RETRIEVED. THIS CASE WAS ALSO SCHEDULED WRONG. IT WAS SCHEDULED FOR OPEN HERNIA, BUT PATIENT CHANGED MIND AFTER HE WAS AT THE HOSPITAL AND WANTED LAPAROSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEFLEX MEDICAL TAUT 10/12M BALLOON NONE GCJ TELEFLEX MEDICAL 41244 01K0800236

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability