BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM

    MDR report key: 1914259 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06859
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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 WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: (B)(6).

    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 ON (B)(6) 2010 AND THEN WAS ADMITTED FOR OBSERVATION AND RECEIVED FOUR UNITS OF BLOOD. 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 ECHELON* 60 ENDOPATH** STAPLER LONG ENDOSCOPIC LINEAR CUTTER - STRAIGHT 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R CARTRIDGE