BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 17738479 · Received September 13, 2023

    Report

    Report Number
    3003139373-2023-00203
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 29, 2023
    Manufacturer
    CELESTICA DE MONTERREY S.A. DE C.V.
    Product Code
    GDW
    UDI-DI
    10884523002829
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 030451, 030451 ROTICULTR ENDO GIA 30-2.5 DLU (LOT#T2E142X). 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

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE DEVICE WAS APPLIED ON OVER INDICATED TISSUE. ADDITIONALLY, THE DEVICE HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. IT WAS REPORTED THAT THE DEPLOYED STAPLES DID NOT HOLD THE TISSUE AND THE STAPLE LINE OPENED UP. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN AN OBSTACLE HAS BEEN INCORPORATED IN THE JAWS DURING APPLICATION. APPLICATION OVER TISSUE THAT WAS BEYOND THE RECOMMENDED THICKNESS RANGE. APPLICATION WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN ANY 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 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: WHEN POSITIONING THE STAPLER ON THE APPLICATION SITE, ENSURE THAT NO OBSTRUCTIONS, SUCH AS CLIPS, ARE INCORPORATED INTO THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND IMPROPERLY FORMED STAPLES. SELECT A LOADING UNIT WITH THE APPROPRIATE STAPLE SIZE FOR THE TISSUE THICKNESS. OVERLY THICK OR THIN TISSUE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION. ALWAYS INCLUDE THE COMBINED THICKNESS OF THE TISSUE AND OF ANY STAPLE LINE REINFORCEMENT MATERIAL IN USE WHEN CHOOSING THE PROPER STAPLE CARTRIDGE. 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, POST-OPERATIVELY OF A LAPAROSCOPIC PNEUMONECTOMY WHERE THE DEVICE WAS USED TO ANASTOMOSE VESSEL WITH NO ISSUES, AFTER THE SURGERY WITH THE PATIENT STILL IN THE OR, THE SURGEONS NOTICED BLOOD IN THE DRAIN. THE PATIENT¿S BLOOD PRESSURE DRASTICALLY DECREASED TO 30/10 MMHG. THERE WAS CESSATION OF CIRCULATION IN THE MECHANISM OF PULSELESS ELECTRICAL ACTIVITY. THE ANESTHESIOLOGIST BEGAN RESUSCITATION, IN THE MEANTIME THE SURGEON OPENED THE CHEST OF THE PATIENT AND STOPPED THE BLEEDING. THE SURGEON NOTICED AFTER OPENING THE CHEST, THAT THE TWO STAPLE LINES WERE OPENED/BROKEN, AND THE BLEEDING WAS IN THAT PLACE. THE PATIENT HAD AN ISCHEMIC STROKE. THERE WAS BLOOD LOSS OF MORE THAN 500CC WHICH REQUIRED THE PATIENT A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 120 MINUTES DUE TO THE PRODUCT PROBLEM. THE PATIENT IS STILL IN THE HOSPITAL. CONSEQUENTLY, AFTER THE STROKE, THE PATIENT HAS RIGHT HEMIPARESIS WITH APHASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89179 ENDO GIA STAPLE, IMPLANTABLE GDW CELESTICA DE MONTERREY S.A. DE C.V. 030451 T2E142X 10884523002829

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male PLEASE SEE NOTE ON H10