BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 1914149 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06840
    Event Type
    Injury
    Date Received
    December 3, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. SURGEON USES CLIPS OR OVER SEWS ANY BLEEDING ON THE STAPLE LINES. HE RARELY BOVIES THE STAPLE LINES. HE USES 3.0 VICRYL FOR AN ANTERIOR STITCH ON THE GJ AND STITCHES ANY PERFORATED VESSELS. 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 POST OP OF A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PATIENT HAD A POST OP BLEED THE NIGHT OF SURGERY AND RECEIVED A BLOOD TRANSFUSION. THE PATIENT WAS PASSING BLOOD. IT IS UNKNOWN IF THE PATIENT IS STILL IN THE HOSPITAL. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THE SURGEON DID NOT MENTION THE DEVICE FUNCTION DURING THE ORIGINAL SURGERY DATE. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R