BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 8330998 · Received February 12, 2019

    Report

    Report Number
    1219930-2019-00814
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    December 12, 2018
    Report Date
    April 3, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543591
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC AND FUNCTIONAL EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PHOTOS NOTED THE PROXIMAL END OF THE RELOAD WAS BROKEN. A VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED FOUR OF THE RELOADS WERE OPENED AND HAD FULL COMPLEMENTS OF STAPLES. THE REMAINING TWO RELOADS WERE SEALED IN THEIR PACKAGING, BUT THEY STILL HAD DAMAGE TO THEIR ADAPTERS. ONE OF THE SEALED PACKAGES WAS BROKEN ON ONE SIDE. ADDITIONALLY, THE RETURN INCLUDED THE EMPTY RIPPED DOWN BLISTERS FROM THE DAMAGED UNITS THAT HAD BEEN UNPACKAGED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THIS FASHION OF UNIT AND BLISTER DAMAGE IS CONSISTENT WITH THAT WHICH OCCURS WHEN A BOX OF PACKAGED RELOADS IS DROPPED OR OTHERWISE HANDLED IN AN ABUSIVE MANNER. RELOADS ARE FULLY INSPECTED PER SOP AT THE PACKAGING STATION ACROSS ALL TRI-STAPLE CELLS PRIOR TO BEING PLACED IN THE BLISTER, AS WELL AS AFTER SEALING AND BEFORE BEING PLACED SIX TO A BOX. DUE TO THE AFFECTED UNITS ALL COMING FROM THE SAME BOX ENGINEERING CONCLUDES THAT THE DAMAGE IS THE RESULT OF EXCESSIVE HANDLING, AND IS NOT CONTRIBUTED TO THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PHOTOS NOTED THE PROXIMAL END OF THE RELOAD WAS BROKEN. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITION. WITHOUT THE PHYSICAL PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR TO USE, THEY TRIED TO PLACE THE RELOAD ON THE STAPLER HOWEVER THE RELOAD WOULD NOT ATTACH TO THE ADAPTER. THE PROXIMAL END OF THE RELOAD WHICH ATTACHES TO THE DISTAL END OF THE ADAPTER WAS CROOKED. THERE WAS NOT A STAPLE LINE INVOLVED BECAUSE THE DEFORMED RELOADS WERE NOTICED PRIOR TO PATIENT ENTERING THE ROOM. THE PROXIMAL END OF THE RELOAD WHERE THE ¿WHITE CHIP¿ IS LOCATED (FOR ENABLING INTELLIGENT TECHNOLOGY) THAT IN THAT AREA IS WHERE YOU¿LL FIND THE RELOAD TO BE BROKEN. AN ENTIRE BOX OF RELOADS WERE BROKEN. THEY DID NOT NEED TO OPEN ALL OF THE RELOADS TO SHOW ME BECAUSE IT CAN BE SEEN FROM THE STERILE PACKAGING. A DIFFERENT LOT NUMBER OF RELOADS WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124150 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIG60AXT N8J1005X 10884521543591

    Patients

    Seq Age Sex Outcome Treatment
    1