BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA XL 25MM SINGLE-USE STAPLER

    MDR report key: 6123497 · Received November 22, 2016

    Report

    Report Number
    2647580-2016-01000
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 26, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. THE TROCAR TIP WAS RECEIVED ATTACHED AND SECURED TO THE ANVIL. FUNCTIONALLY, THE DEVICE WAS APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY, DESPITE THE NOTED KNIFE BLADE DAMAGE. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT MET SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITION. REPLICATION OF THE OBSERVED SECONDARY, KNIFE BLADE DAMAGE MAY OCCUR IF THE INSTRUMENT IS APPLIED OVER AN OBSTRUCTION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. HOWEVER, THE INVESTIGATION DETECTED A SECONDARY CONDITION OF KNIFE BLADE DAMAGE THAT HAS NO RELATIONSHIP TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RECEIVED BUT EVALUATION NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. BASED ON ADDITIONAL INFORMATION RECEIVED, THIS REPORT HAS BEEN REEVALUATED AND DETERMINED TO BE A MALFUNCTION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A LAP GASTRIC BYPASS, INVOLVING THE STOMACH, ANVIL TIP CAME OFF FROM END OF THE STAPLER. CURRENT PATIENT STATUS IS NORMAL. TO CORRECT THE CONDITION, THE ANVIL WAS CUT OUT AND OPENED NEW STAPLER AND CONTINUED WITH PROCEDURE. SEAMGUARD REINFORCEMENT MATERIAL WAS USED. THE DIFFICULTY DID NOT RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION ETC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO IRREVERSIBLE TISSUE DAMAGE. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. NO DEVICE FRAGMENT FELL INTO THE PATIENT. NO DEVICE FRAGMENT WAS LEFT IN PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED PER PHONE CALL WITH SALES REP: DURING THE CASE THE ANVIL TIP FELL OUT FROM ANVIL AND FELL INTO PATIENT. TIP WAS RETRIEVED WITHOUT INCIDENT AND A NEW DEVICE WAS OPENED TO CONTINUE THE SURGERY. NO IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773852 EEA XL 25MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEAXL25 P6E0314KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention