BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1851258 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05658
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    June 1, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH FORM, (B)(4), DURING A BOWEL RESECTION PROCEDURE, THE GIA STAPLER HAD BEEN USED TO RESECT THE BOWEL AND WAS RELOADED TO RESECT ANOTHER SECTION, BUT THERE WAS INCOMPLETE FIRING OF THE STAPLES. THE STAPLES DID NOT GO ACROSS THE BOWEL; THIS THEN REQUIRED FURTHER BOWEL RESECTION AND USE OF A DIFFERENT STAPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ADVANCING THE DEVICE THROUGH THE SCOPE, THE BLUE PAINT ON THE DISTAL TIP WAS PEELING AND THE DISTAL END BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR