BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 5113102 · Received September 30, 2015

    Report

    Report Number
    2647580-2015-00695
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 9, 2015
    Report Date
    October 22, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE OVAL BALLOON DISSECTOR OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE REPORTED CONDITION FOR THIS INCIDENT STATES THAT THE DEVICE MALFUNCTIONED DURING AN INGUINAL HERNIA REPAIR PROCEDURE. UPON INITIAL INSPECTION, A CUT WAS OBSERVED TO PENETRATE THE TROCAR BALLOON. DUE TO THE OBSERVED DAMAGE, THE TROCAR BALLOON WOULD NOT INFLATE PROPERLY. ALL OTHER COMPONENTS WERE IN PROPER WORKING CONDITION. IN ADDITION; THERE WAS NO OTHER VISUAL ABNORMALITIES OBSERVED DURING THE EVALUATION. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE TO THE HOLE IN THE BALLOON, THE REPORTED CONDITION WAS CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF COMPLAINT DATA REVEALS NO TREND FOR A DEVICE RELATED FAILURE FOR THIS CONDITION. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR THE DEVICE DISENGAGED INTO CAVITY AND IT WAS RETRIEVED. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO AN OPEN PROCEDURE IN ORDER TO RETRIEVE THE MISSING SHEAF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645802 SM PLUS SBT/OVAL BALLOON DISSECTOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC SMSBTOVL P5D0037X

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention