BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 212159 · Received March 1, 1999

    Report

    Report Number
    1527736-1999-01157
    Event Type
    Malfunction
    Date Received
    March 1, 1999
    Date of Event
    February 17, 1999
    Report Date
    February 23, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE USED DURING A BILATERAL TOTALLY EXTRAPERITONEAL REPAIR. IT WAS REPORTED BY THE REP THAT DURING A BILATERAL TOTAL EXTRAPERITONEAL REPAIR, THE EMS STAPLER MISFIRED AND JAMMED. THE HOSPITAL WAS NOT STOCKING THE EMS SEPARATELY SO THE CIRCULATOR OPENED ANOTHER FDH39 KIT. THIS STAPLER JAMMED ALSO. A THIRD KIT WAS OPENED AND THE CASE WAS COMPLETED LAPAROSCOPICALLY WITH THE THIRD EMS. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS GAG ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other