BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 144807 · Received January 14, 1998

    Report

    Report Number
    1527736-1998-00128
    Event Type
    Malfunction
    Date Received
    January 14, 1998
    Date of Event
    November 2, 1997
    Report Date
    December 1, 1997
    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 #.48493. EES #.980195/J. D5; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EMS WAS USED DURING A PROLAPSE PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THE DEVICE JAMMED AND THE STAPLES WERE NOT DELIVERED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K48335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other