BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRPT PLUS V2 12MM OBTR +5MM-12MM SEAL RT

    MDR report key: 6113962 · Received November 18, 2016

    Report

    Report Number
    9612501-2016-00924
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 21, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K952977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION ONE DEVICE 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 CIRCULAR SEAL WAS CUT. THE ENVELOPE SEALS WERE INTACT. THE CANNULA AND THE OBTURATOR WERE NOT RECEIVED. REPLICATION OF THE OBSERVED DAMAGE MAY OCCUR AS A RESULT OF A SHARP INSTRUMENT MAKING CONTACT WITH THE CIRCULAR SEAL. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE PRODUCT ANALYSIS CONCLUDED THERE WERE NO DEVICE ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THEREFORE, OUR INVESTIGATION WAS UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A LAP COLECTOMY OF THE CECUM WITH TERMINAL ILEUM PROCEDURE, THEY FOUND A BLUE FOREIGN MATERIAL IN THE ABDOMINAL CAVITY. IT WAS IMMEDIATELY RETRIEVED. THE EVENT OCCURRED IN USE FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS NOT EXTENDED. THE STATUS OF THE PATIENT IS WITH NO PROBLEM. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. NO BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765183 VRPT PLUS V2 12MM OBTR +5MM-12MM SEAL RT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN 179103P

    Patients

    Seq Age Sex Outcome Treatment
    1