BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1902441 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06585
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED THE FOLLOWING RESPONSE ON (B)(6) 2011: THE SALES REP SAID THAT THE HOSPITAL DID NOT KNOW THESE ANSWERS. THE ONLY INFORMATION THAT THEY HAVE IS THAT THE STAPLER LOCKED IN THE FIRST FIRING AND THE DEVICE DID NOT RESPOND TO THE COMMAND, SO THEY REPLACE IT FOR ANOTHER ONE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FORCEPS DID NOT RESPOND TO THE COMMANDS OF OPENING AND CLOSING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05513. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE NC QUANTUM APEX MR 15MM X 2.00MM BALLOON BURST AT FIFTEEN ATMOSPHERES ON THE SECOND INFLATION. THEY PULLED A NC QUANTUM APEX MR 15MM X 2.25MM BALLOON. THIS BALLOON BURST AT FIFTEEN ATMOSPHERES ON THE SECOND INFLATION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. F4NY6G

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE