BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 161700 · Received April 6, 1998

    Report

    Report Number
    1527736-1998-01064
    Event Type
    Malfunction
    Date Received
    April 6, 1998
    Date of Event
    March 9, 1998
    Report Date
    March 10, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    8/19/1998 FURTHER INVESTIGATION HAS FOUND THAT THIS IS A DUPLICATE OF EES#981935 MEDWATCH# 1527736-1998-01065, 1527736-1998-01066

    Description of Event or Problem · 1

    IT WAS REPORTED THE EMS WAS USED DURING A TAP HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE THE CLIPS GET STUCK IN THE TIP OF THE INSTRUMENT WHEN TRIED TO FIRE IT. NO MORE CLIPS CAN THEN BE FIRED. A MALFORMED CLIP WAS STUCK IN THE JAW AND PREVENTED THE OTHER CLIPS FROM FEEDING. ANOTHER EMS WAS USED TO COMPLETE THE CASE. 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 K48J62

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other