BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA

    MDR report key: 13996167 · Received April 4, 2022

    Report

    Report Number
    2647580-2022-01120
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    January 3, 2022
    Report Date
    June 22, 2022
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884521031661
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE INSTRUMENT HAD BEEN PARTIALLY APPLIED. FUNCTIONALLY, THE SINGLE USE LOADING UNIT WAS RESET AND LOADED INTO THE INSTRUMENT. THE SINGLE USE LOADING UNIT UNLOADED AND LOADED REPEATEDLY WITHOUT DIFFICULTY. THE SINGLE USE LOADING UNIT AND INSTRUMENT WERE APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS. THE FIRING KNOB ADVANCED AND RETRACTED WITHOUT DIFFICULTY. THE KNIFE CUT COMPLETELY AND CLEANLY. THE STAPLES DEPLOYED AND FORMED PROPERLY. IT WAS REPORTED THAT THE DEVICE DID NOT FIRE. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR IF THE FIRING STROKE IS NOT COMPLETE AND THE FIRING KNOB IS NOT FULLY RETRACTED AFTER FIRING OR IF THE INSTRUMENT IS APPLIED AGAINST AN EXCESSIVE AMOUNT OF TISSUE DURING THE CLINICAL APPLICATION. IF THE FIRING KNOB IS NOT FULLY RETRACTED, DIFFICULTY IN UNLOADING THE LOADING UNIT MAY BE EXPERIENCED, AND MAY PREVENT FURTHER LOADING FROM OCCURRING. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: TO REMOVE THE SINGLE USE LOADING UNIT, SEPARATE THE INSTRUMENT HALVES. HOLD THE CARTRIDGE-HALF OF THE INSTRUMENT, GRASP THE PROXIMAL END OF THE SINGLE USE LOADING UNIT TABS AND PULL UP AND OUT TO REMOVE THE SINGLE USE LOADING UNIT FROM THE INSTRUMENT. TO PLACE A NEW SINGLE USE LOADING UNIT INTO THE INSTRUMENT, HOLD THE SINGLE USE LOADING UNIT BY THE PROXIMAL END TABS AND INSERT INTO THE CARTRIDGE FORK AT A 30 TO 45 DEGREE ANGLE FROM THE DISTAL END DOWN UNTIL THE UNIT SNAPS INTO PLACE. REMOVE SHIPPING WEDGE AFTER SINGLE USE LOADING UNIT IS FULLY LOADED. SINGLE USE LOADING UNIT WILL ¿FLOAT¿ UP AND DOWN IN FINAL LOADED POSITION. 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 A PROCEDURE, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604462 GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO GIA10038L P0F0177Y 10884521031661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown