BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3052451 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01724
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION PROVIDED: HOW WAS IT CONFIRMED THAT THE ANVIL WAS SECURED TO THE TROCAR? THE SAW IT HE HAVE FEEL IT AND USE OUR SPECIAL ANWILDEVICE. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? FEEDBACK OF CRUNCH, BUT HE DON'T FEEL SO STRONG LIKE NORMALLY. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? CA. 1.5 TO 1.8. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES. IF THE DEVICE DID NOT STAPLE AND CUT AS INTENDED, PLEASE EXPLAIN WHAT THE ISSUE WAS. DEVICE DIDN'T STAPLING, NO STAPLER IN THE DEVICE. WERE THERE TWO COMPLETE TISSUE DONUTS? UNKNOWN. WHO FIRED THE DEVICE? SURGEON. HAS THE PERSON FIRING BEEN TRAINED ON HOW TO USE THE EES CIRCULAR DEVICE? YES HE USED IT MORE THAN 10 YEARS AND 100 EACH/YEAR. HAS THE O.R. STAFF BEEN TRAINED IN PREPARING THE EES CIRCULAR DEVICE? YES. WHAT IS THE CURRENT STATUS OF THE PATIENT? HE REPAIR THE ISSUE WITH A NEW RESECTION AND NEW DEVICE. PATIENT'S OUTCOME IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CONTINUITY RE-ESTABLISHMENT PROCEDURE THE SURGEON SAID THAT WHEN HE RE-OPENED THE CIRCULAR STAPLER, THE ANVIL STAYED INSIDE THE RECTUM OF THE PATIENT AND THAT HE HAD TO TAKE A RECTOSCOPE TO TAKE BACK THE ANVIL. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE. DEVICE HAS BEEN DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154285 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C397

    Patients

    Seq Age Sex Outcome Treatment
    1