BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTRISAIL 36 FR. GASTRIC POS

    MDR report key: 4863432 · Received June 23, 2015

    Report

    Report Number
    1219930-2015-00493
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 12, 2015
    Report Date
    October 9, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    KNT
    PMA / PMN Number
    K143088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT WITHOUT. 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, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. THE DEVICE FUNCTIONED AS DESIGNED. THIS DEVICE WAS COILED IN THE PACKED UPON RECEIPT. EVEN THROUGH THESE THERMOPLASTICS TOOK A SET IN THE RETURN PACKAGE, THE DEVICE WAS CAPABLE OF DEPLOYING AND RETRACTING COMPLETELY. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SUBSEQUENTLY, THE COMPLAINT DATA DID NOT DISPLAY AN INCREASED TREND. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED AS A RESULT OF THE ALLEGED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY PRE OP DIAGNOSIS: MORBID OBESITY ANATOMY INVOLVED: STOMACH, ESOPHAGUS ACCORDING TO THE REPORTER: ANESTHESIA APPLIED SUCTION AND PULLED BACK SAIL UNTIL REACHING BLACK LINE. HOWEVER, SAIL DIDN'T GO BACK INTO GROOVE ALL THE WAY. ANES. PULLED BACK HARDER AND WE HEARD A CRACK AND SAIL STILL DIDN'T RETRACT ALL THE WAY. ANES. TOOK OFF SUCTION AND DOCTOR MANUALLY PUSHED SAIL INTO TRACK. ANES. PULLED AGAIN AND HEARD ANOTHER CRACK. THERE WAS NO PATIENT INJURY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. WHILE INSERTING SAIL IN BEGINNING OF CASE, ANES. STRUGGLED A LITTLE. ANES. MAY HAVE TWISTED DEVICE A LITTLE WHICH COULD HAVE AFFECTED ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405410 GASTRISAIL 36 FR. GASTRIC POS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN, FORMERLY US SURGICAL A DIVISON GPS36 E5D0001X

    Patients

    Seq Age Sex Outcome Treatment
    1