BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 346225 · Received August 9, 2001

    Report

    Report Number
    1527736-2001-04206
    Event Type
    Injury
    Date Received
    August 9, 2001
    Report Date
    July 24, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE, THE STAPLER WAS NOT FIRING PROPERLY. THE MESH CAME LOOSE FROM THE ABDOMINAL WALL SEVERAL DAYS POST-OP. RE-OPERATION WAS PERFORMED TO REPAIR MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36092 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention