BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES

    MDR report key: 5390278 · Received January 26, 2016

    Report

    Report Number
    2647580-2016-00036
    Event Type
    Death
    Date Received
    January 26, 2016
    Date of Event
    December 7, 2015
    Report Date
    January 4, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKING NO: (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKING NO: (B)(4). D10: DEVICE RETURNED 2/22/2016.

    Additional Manufacturer Narrative · 0

    TRACKING NO: (B)(4). H 3: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES AND ONE DST SERIES EEA ORVIL 25MM DEVICE OPENED BY THE ACCOUNT. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. THE ORVIL ANVIL WAS OBSERVED TO BE TILTED AND SEPARATED FROM THE INSTRUMENT. HOWEVER, ONE OF THE RETAINER LEGS OF THE ORVIL ANVIL WAS OBSERVED TO BE BENT. FUNCTIONALLY, A PMV REPRESENTATIVE ORVIL ANVIL WAS USED FOR FIRING DUE TO THE OBSERVED RETAINER LEG DAMAGE OF THE CLINICAL ORVIL ANVIL. THE DEVICE WAS APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY AND THE PUSHERS ADVANCED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE OBSERVED ORVIL ANVIL DAMAGE MAY OCCUR IF THE ORVIL ANVIL IS MANIPULATED WITH EXCESSIVE FORCE DURING THE ATTACHMENT TO THE INSTRUMENT, OR IF THE ORVIL ANVIL IS MISHANDLED DURING THE REMOVAL FROM THE TUBING. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    TRACKING NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 01/27/2016 CLARIFICATION WAS RECEIVED FROM THE REPORTER (IN (B)(6)) WHEN ASKED WHAT WAS MEANT BY THE STATEMENT, THE PATIENT PASSED OUT 1 MONTH AFTER THE PROCEDURE THE REPLY WAS: PATIENT CURRENT STATUS: PASSED AWAY. THE DATE OF DEATH, CAUSE OF DEATH AND MANNER IS UNKNOWN. THE DEVICE HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, IT WAS NOT POSSIBLE TO MAKE A MECHANICAL ANASTOMOSIS WITH THE DEVICE. THE ORVIL ANVIL COULDN'T CLIP PROPERLY. A LAPAROTOMY WAS MADE, THE PROCEDURE WAS CONVERTED TO OPEN. ADDITIONAL INFORMATION RECEIVED ON JAN13-2016: THE DEVICE WAS APPLIED IN THE SMALL INTESTINE. WHILE MAKING THE ANASTOMOSIS, THE ANVIL COULD NOT BE CLIPPED IN THE EEA DEVICE. THE DEVICE WAS USED WITHIN THE PATIENT, THE SURGERY TIME WAS EXTENDED, AND THERE WAS UNANTICIPATED TISSUE DAMAGE. A FISTULA WAS NOTICED 5 DAYS AFTER THE PROCEDURE. THE PATIENT REPORTEDLY PASSED OUT 1 MONTH AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49315 EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES IMPLANTABLE STAPLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EEAXL2535 P4D0262KX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability| R| O| D