BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH SHEATH CIR STAPLER

    MDR report key: 1053141 · Received May 15, 2008

    Report

    Report Number
    1527736-2008-03051
    Event Type
    Injury
    Date Received
    May 15, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWELVE HOURS POST LAP GASTRIC BYPASS, THE PATIENT WAS BROUGHT BACK FOR AN INTRA-LUMINAL GASTRIC POUCH BLEED. THE STOMACH WAS EVACUATED OF ALL THE BLOOD AND THE ANASTOMOSIS WAS OVERSEWN. PATIENT'S BLOOD CRIT HAD DROPPED, BUT IT WAS UNKNOWN IF ANY BLOOD PRODUCTS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH SHEATH CIR STAPLER KOG ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention