BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 6118558 · Received November 21, 2016

    Report

    Report Number
    2647580-2016-00990
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 25, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE BALLOON. A CUT WAS OBSERVED TO PENETRATE THE BALLOON. THE BALLOON WAS UNABLE TO BE INFLATED DUE TO THE OBSERVED CUT. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF EITHER AN INFLATED OR DEFLATED BALLOON MAKING CONTACT WITH A SHARP OBJECT DURING USE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TEP PROCEDURE, THE BALLOON COULDN'T BE INFLATED DURING OPERATION. THERE WAS NO PATIENT HARM. THE DEVICE WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767826 SPACEMAKER PREPERITONEAL DIST BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMSPDB1000 P6A0399X

    Patients

    Seq Age Sex Outcome Treatment
    1