BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS45

    MDR report key: 1726583 · Received June 14, 2010

    Report

    Report Number
    3005075853-2010-03189
    Event Type
    Injury
    Date Received
    June 14, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PROCEDURE WAS COMPLETED AND THE ANASTOMOSIS WAS TESTED WITH NO LEAKS. THE NEXT DAY (B) (6), 2010, THE PATIENT PRESENTED WITH A GJ ANASTOMOSIS LEAK. THE PATIENT RETURNED TO SURGERY THE NEXT DAY FOR REPLACEMENT OF THE INTER-GASTRIC STENT AT THE GJ ANASTOMOSIS. STENT HAS BEEN REMOVED AND THE LEAK WAS RESOLVED. THE PATIENT IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHEN THE SURGEON FIRED THE DEVICE, THE DEVICE CUT BUT DID NOT STAPLE, NO STAPLE DEPLOYED. THIS WAS THE FIRST FIRING TO CREATE THE GASTRIC POUCH. THE FIRING WAS WITH A BLUE CARTRIDGE. THE DEVICE WAS RELOADED WITH A BLUE CARTRIDGE AND WAS FIRED OVER THE AREA WHERE THE STAPLES DID NOT DEPLOY AT THE FIRST FIRING. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention