BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 6142204 · Received December 2, 2016

    Report

    Report Number
    2647580-2016-01029
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 28, 2016
    Report Date
    April 3, 2024
    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
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKING NUMBER: (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SINGLE-USE STAPLER OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. SINCE THE CLINICAL ANVIL WAS NOT RECEIVED, A PMV REPRESENTATIVE ANVIL WAS USED FOR ALL FUNCTIONAL TESTING. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. FUNCTIONALLY, THE DEVICE WAS RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED TO THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE MEDIA CLEANLY AND COMPLETELY AND A FULL COMPLEMENT OF STAPLES WAS DEPLOYED AND PROPERLY FORMED, DESPITE THE NOTED KNIFE BLADE DAMAGE. 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 KNIFE BLADE DAMAGE MAY OCCUR IF THE INSTRUMENT IS APPLIED OVER AN OBSTRUCTION. BASED ON THE PRODUCT ANALYSIS, THE FAILURE WAS CONFIRMED TO BE ATTRIBUTED TO THE REPORTED EVENT. 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 OR THE STAPLE LINE MAY NOT PROPERLY FORM. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PER FDA REQUEST, THIS REPORT WAS ELECTRONICALLY RESUBMITTED. LEGACY CODING: METHOD (10, 3355, 3332, 38); RESULTS (3243); CONCLUSION (61). TRACKING NUMBER: (B)(4), H.3.: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE SINGLE-USE STAPLER OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. SINCE THE CLINICAL ANVIL WAS NOT RECEIVED, A PMV REPRESENTATIVE ANVIL WAS USED FOR ALL FUNCTIONAL TESTING. A MICROSCOPE EXAMINATION OF THE DEVICE DISPLAYED NICKS ON THE KNIFE BLADE. FUNCTIONALLY, THE DEVICE WAS RELOADED WITH A FULL COMPLEMENT OF STAPLES AND APPLIED TO THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE MEDIA CLEANLY AND COMPLETELY AND A FULL COMPLEMENT OF STAPLES WAS DEPLOYED AND PROPERLY FORMED, DESPITE THE NOTED KNIFE BLADE DAMAGE. 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 KNIFE BLADE DAMAGE MAY OCCUR IF THE INSTRUMENT IS APPLIED OVER AN OBSTRUCTION. BASED ON THE PRODUCT ANALYSIS, THE FAILURE WAS CONFIRMED TO BE ATTRIBUTED TO THE REPORTED EVENT. 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 OR THE STAPLE LINE MAY NOT PROPERLY FORM. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION NOT PROVIDED. RE-PROCESSING INFORMATION NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A COLOSTOMY CLOSURE, THERE WAS NO TACTILE CLICK AFTER FIRING AND OPENING. THERE WAS NO ISSUES FIRING THE DEVICE, BUT WHEN THEY DID THE LEAK TEST, THEY DID OBSERVE BUBBLES AND HAD TO OVER-SEW. A COMPLETE STAPLE CIRCLE WAS ABLE TO BE FIRED AND THE DEVICE CUT PROPERLY. THE DEVICE WAS ALSO ABLE TO BE REMOVED WITHOUT ANY DIFFICULTY. CURRENT PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792860 EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P6J0043KX 10884523005530

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention