BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 6038478 · Received October 18, 2016

    Report

    Report Number
    2647580-2016-00840
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    UDI-DI
    10884523005530
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION UNDER THE MICROSCOPE DISPLAYED NICKS ON THE KNIFE BLADE. THE STAPLER WAS RELOADED AND APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS. THE REPORTED CONDITION WAS CONFIRMED. REPLICATION OF THE OBSERVED 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. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE SURGEON RESECTED THE COLON AND DETERMINED A 28 WOULD BE THE BEST SIZE FOR THE PATIENT. THE PA THEN FIRED THE STAPLER AND NOTICED THE DONUTS WERE COMPLETE. THEY DID ENDOSCOPY TO LOOK AT THE ANASTOMOSIS AND TEST. BUBBLES WERE OBSERVED. THERE WAS A DIVERTICULUM NEAR THE STAPLE LINE AND THERE WERE ALSO BUBBLES COMING FROM THE STAPLE LINE AREA. THE STAPLE LINE APPEARED TO BE INTACT. THE SURGEON HAD TO OVERSEW THE DIVERTICULUM AND THE STAPLE LINE. THE STAPLER SEEMED TO ACT APPROPRIATELY IN ALL STEPS OF THE FIRING PROCESS. SURGERY TIME WAS DELAYED BY MORE THAN 30 MINUTES. THE DELAY DID NOT AFFECT THE PATIENT IN ANY WAY. THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689781 EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P6H0272KX 10884523005530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R