BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 5289224 · Received December 11, 2015

    Report

    Report Number
    2647580-2015-00885
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 17, 2015
    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
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ILEOSTOMY IS TEMPORARY. NO REINFORCEMENT MATERIAL WAS USED. CORRECTED INFORMATION 510K IS K062850. POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE EEA 31MM SINGLE-USE STAPLER OPENED BY THE ACCOUNT. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. THE ANVIL OF THE INSTRUMENT WAS NOT RECEIVED. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. SINCE THE CLINICAL ANVIL WAS NOT RECEIVED, A REPRESENTATIVE ANVIL WAS USED FOR ALL FUNCTIONAL TESTING. FUNCTIONALLY, THE DEVICE WAS RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY, DESPITE THE NOTED KNIFE BLADE DAMAGE AND THE STAPLE LINE WAS PROPERLY FORMED. 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 SECONDARY, UNRELATED TO THE REPORTED CONDITION KNIFE BLADE DAMAGE MAY OCCUR IF THE INSTRUMENT IS APPLIED OVER AN OBSTRUCTION. THE INFORMATION BOOKLET CAUTIONS THE USER TO MAKE CERTAIN THE SECTION OF THE TISSUE TO BE STAPLED IS FREE FROM ANY METAL CLIPS OR SIMILAR STRUCTURES; OTHERWISE, THE KNIFE BLADE MAY NOT CUT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A COLOSTOMY CLOSURE, THE DEVICE MISFIRED. THE STAPLES DID NOT MAKE A PURCHASE ON THE PROXIMAL SIDE OF THE COLON IN AN END TO END ANASTOMOSIS. THIS LED TO ADDITIONAL TRANSECTION AND ILEOSTOMY SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818415 EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA31 P4F0117KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R