BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER EMS

    MDR report key: 153791 · Received February 27, 1998

    Report

    Report Number
    1527736-1998-00557
    Event Type
    Malfunction
    Date Received
    February 27, 1998
    Report Date
    January 30, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49494. EES #.981003/J. D5, H4: INFORMATION NOT AVILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EMS WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE THE STAPLES COULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER EMS ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K68K01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other