BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ULTRA

    MDR report key: 9088722 · Received September 19, 2019

    Report

    Report Number
    2647580-2019-04668
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 20, 2019
    Report Date
    March 11, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003543
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE DEVICES. INITIAL VISUAL INSPECTION OF THE INSTRUMENTS NOTED NO ABNORMALITIES. FUNCTIONALLY, THE FIRST AND SECOND INSTRUMENTS WERE LOADED WITH AN ENDO GIA* 60MM ARTICULATING VASCULAR/MEDIUM RELOAD. DURING THE FIRING CYCLE, A SKIP WAS AUDIBLE IN EACH INSTRUMENTS FIRING STROKE. AN ACCESS HOLE WAS CUT INTO EACH INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACKS. THIS EXAMINATION NOTED SHEARED TEETH ON EACH INSTRUMENT FIRING RACK. THE THIRD INSTRUMENT WAS THEN SUCCESSFULLY LOADED WITH A SINGLE USE LOADING UNIT. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. THE FORTH INSTRUMENT WAS REMOVED FROM THE SEALED BLISTER PACKAGE FOR FUNCTIONAL TESTING. THE INSTRUMENT WAS SUCCESSFULLY LOADED WITH A SINGLE USE LOADING UNIT. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. 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 THE SHEARED TEETH ON THE FIRING RACK MAY OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 1. FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN EITHER OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY, AND TISSUE MAY NOT BE FULLY TRANSECTED. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT OFFERS THE FOLLOWING AS A WARNING AND PRECAUTION. "1. PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS FOUND TO BE DUE TO THE DEVICE 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.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY H3 EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE OPENED SINGLE USE INSTRUMENTS AND ONE REPRESENTATIVE SEALED UNIVERSAL 12MM SINGLE USE INSTRUMENT. INITIAL VISUAL INSPECTION OF THE INSTRUMENTS NOTED NO ABNORMALITIES. FUNCTIONALLY, THE FIRST AND SECOND INSTRUMENTS WERE LOADED WITH AN ARTICULATING VASCULAR/MEDIUM RELOAD. DURING THE FIRING CYCLE, A SKIP WAS AUDIBLE IN EACH INSTRUMENTS FIRING STROKE. AN ACCESS HOLE WAS CUT INTO EACH INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACKS. THIS EXAMINATION NOTED SHEARED TEETH ON EACH INSTRUMENT FIRING RACK. THE THIRD INSTRUMENT WAS THEN SUCCESSFULLY LOADED WITH A REPRESENTATIVE SINGLE USE LOADING UNIT. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. THE FOURTH INSTRUMENT WAS REMOVED FROM THE SEALED BLISTER PACKAGE FOR FUNCTIONAL TESTING. THE INSTRUMENT WAS SUCCESSFULLY LOADED WITH A REPRESENTATIVE SINGLE USE LOADING UNIT. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. 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 THE SHEARED TEETH ON THE FIRING RACK MAY OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 1. FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN EITHER OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY, AND TISSUE MAY NOT BE FULLY TRANSECTED. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT OFFERS THE FOLLOWING AS A WARNING AND PRECAUTION. "1. PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. HOWEVER, THE COULD NOT SQUEEZE THE HANDLE. HENCE, THE STAPLER WOULD NOT FIRE. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO PRODUCT PROBLEM. SURGICAL TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882595 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND P8A0729X 10884523003543

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention