BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM)

    MDR report key: 6085371 · Received November 8, 2016

    Report

    Report Number
    2647580-2016-00936
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE EEA 31MM SINGLE-USE STAPLER. 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. INSPECTION OF THE ANVIL CUTTING RING SHOWED DEEP TRACES OF KNIFE IMPRESSION AND THE RING WAS RECEIVED COMPLETELY SEVERED. FUNCTIONALLY, THE DEVICE RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE REPORTED CONDITION WAS CONFIRMED, DUE TO THE NICKS ON THE KNIFE BLADE. REPLICATION OF THE OBSERVED 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 MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; DURING A COLECTOMY PROCEDURE THE STAPLER DIDN'T FIRE COMPLETELY. THE DONUT SHAPE WAS NOT FORMED COMPLETELY AND THE INCOMPLETE PARTS OF THE STAPLE LINE HAD TO BE OVER SEWN WITH SUTURE. OTHER THAN THE SUTURE USED TO TREAT THE ISSUE, NO OTHER REINFORCEMENT MATERIAL WAS IN USE WITH THE STAPLING DEVICE AT THE TIME. NO DEVICE COMPONENT FELL INTO THE PATIENT, AND THERE WAS NO TISSUE DAMAGE, TISSUE LOSS OR BLOOD LOSS. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 30 MINUTES. THE MOST RECENT REPORT OF THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737535 EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM) STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA31 P6D0725KX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention