BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAMAX

    MDR report key: 8662900 · Received June 3, 2019

    Report

    Report Number
    1219930-2019-03239
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 18, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884521168616
    PMA / PMN Number
    K122781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF FOUR PHOTOGRAPHS AND SEVEN DEVICES. LOADING UNITS ONE AND TWO WERE RECEIVED WITH A FULL COMPLEMENT OF STAPLES AND BOTH INTERLOCKS SET. PHOTOGRAPHIC AND VISUAL INSPECTION NOTED BOTH THUMB PUSHERS WERE DISENGAGED FROM THE LOADING UNITS. VISUAL INSPECTION OF LOADING UNITS THREE, FOUR, FIVE, AND SIX NOTED ALL FOUR LOADING UNITS DISPLAYED A FULL COMPLEMENT OF STAPLES AND THE INTERLOCK WAS ENGAGED. LOADING UNIT SEVEN WAS RECEIVED FULLY APPLIED AND THE INTERLOCK WAS ENGAGED. NO DAMAGE WAS NOTED TO ALL SEVEN KNIFE BLADES. FUNCTIONAL EVALUATION OF THE FIRST TWO LOADING UNITS WERE CONDUCTED BY REATTACHING THE FIRING KNOBS. THE LOADING UNITS WERE THEN LOADED INTO A TEST UNIT. BOTH LOADING UNITS UNLOADED AND LOADED REPEATEDLY WITHOUT DIFFICULTY. THE LOADING UNITS AND TEST INSTRUMENT WERE APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS. LOADING UNITS THREE, FOUR, FIVE, AND SIX WERE RESET AND LOADED INTO A TEST INSTRUMENT. ALL FOUR LOADING UNITS UNLOADED AND LOADED REPEATEDLY WITHOUT DIFFICULTY. THE TEST INSTRUMENTS AND ALL FOUR LOADING UNITS WERE APPLIED TO THE APPROPRIATE TEST MEDIA WITH ACCEPTABLE RESULTS. RECORDS FROM EACH MANUFA CTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE DETACHED FIRING KNOB CONDITION MAY OCCUR IF AN EXCESSIVE UPWARDS FORCE IS APPLIED TO THE FIRING KNOB DURING DISASSEMBLY, OR IF THE KNOB IS NOT FULLY ROTATED TO ONE SIDE PRIOR TO FIRING, CAUSING DETACHMENT. REPLICATION OF THE OBSERVED CONDITION MAY OCCUR AS A RESULT OF THE ENGAGED SAFETY LOCK DUE TO IMPROPER LOADING OF THE CARTRIDGE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING GASTRIC PROCEDURE, FIRING KNOB OF 3 DEVICE CARTRIDGE DISENGAGED AFTER OPENING THE STERILE PACK AND 4 CARTRIDGES THE WHITE SHIELD AUTOMATICALLY COVERED THE BLADE AFTER OPENING THE STERILE PACK. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, FIRING KNOB OF 3 DEVICE CARTRIDGE DISENGAGED AFTER OPENING THE STERILE PACK AND 4 CARTRIDGES THE WHITE SHIELD AUTOMATICALLY COVERED THE BLADE AFTER OPENING THE STERILE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456791 RELIAMAX STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN GIA6038RL N8H0011X 20884521168616

    Patients

    Seq Age Sex Outcome Treatment
    1