BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 16993184 · Received May 24, 2023

    Report

    Report Number
    1219930-2023-02081
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 24, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003178
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EGIA45AMT - EGIA45AMT EGIA 45 ARTIC MED THICK SULU, LOT# P2J0043. UNKNOWN ENDO GI - UNKNOWN ENDO GIA INSTRUMENT, LOT# UNKNOWN ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. RECEIVED ONE BROKEN PIECE OF SHIPPING WEDGE, ONE SHIPPING WEDGE AND ONE DEVICE OPENED BY THE ACCOUNT WITHOUT THE APPROPRIATE PACKAGING. VISUAL INSPECTION NOTED THE SHIPPING WEDGE WAS DAMAGED. IT WAS REPORTED THAT THE SHIPPING WEDGE WAS BROKEN AND A COMPONENT WAS DISASSOCIATED FROM THE DEVICE INTO THE SURGICAL CAVITY. THE REPORTED ISSUES WERE CONFORMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THESE ISSUES MAY OCCUR IF THE SHIPPING WEDGE PULL TAB IS PULLED IN A LATERAL FASHION TOWARDS THE DISTAL END OF THE SULU (SINGLE USE LOADING UNIT) CHANNEL RATHER THAN AWAY FROM THE CHANNEL, OR IF THE LOADING UNIT (LU) IS CLAMPED PRIOR TO REMOVAL OF THE YELLOW SHIPPING WEDGE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY PROCEDURE, WHILE RESECTIONING THE PULMONARY PARENCHYMA, A FRAGMENT THAT SEEMED TO BE PART OF THE YELLOW TAB WAS FOUND IN THE PATIENT'S CAVITY. THE ISSUE OCCURRED IN TWO RELOADS. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENTS UNDER A MIRROR VIEW WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371534 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AVM P2H0238 10884523003178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown