BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA

    MDR report key: 15833654 · Received November 21, 2022

    Report

    Report Number
    1219930-2022-04573
    Event Type
    Death
    Date Received
    November 21, 2022
    Date of Event
    May 4, 2018
    Report Date
    November 21, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523002850
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT/S: PRODUCT ID: UNKNOWN LIGASUR UNKNOWN LIGASURE INSTRUMENT, LOT #:UNKNOWN; PRODUCT ID: UNKNOWN LIGASUR UNKNOWN LIGASURE INSTRUMENT, LOT #:UNKNOWN; PRODUCT ID: UNKNOWN LIGASUR UNKNOWN LIGASURE INSTRUMENT, LOT #: UNKNOWN; PRODUCT ID: 030412 030412 ENDO GIA UNI 60 2.5 DLU X6, LOT #:UNK; PRODUCT ID: 030412 030412 ENDO GIA UNI 60 2.5 DLU X6, LOT #:UNK; PRODUCT ID: 030454 030454 ENDO GIA R/OR 45 2.5MM, LOT #:UNK; PRODUCT ID: UNKNOWN ENDO GI UNKNOWN ENDO GIA INSTRUMENT, LOT #:UNK. TITLE: RANDOMIZED CLINICAL TRIAL OF STAPLER HEPATECTOMY VERSUS LIGASURE¿ TRANSECTION IN ELECTIVE HEPATIC RESECTION SOURCE: BJS 2018; 105: 1119¿1127 ACCEPTED: 4 MAY 2018. 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 LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE EFFICACY AND SAFETY OF PARENCHYMAL TRANSECTION BY THE VESSEL SEALING DEVICE COMPARED WITH THE STAPLER TECHNIQUE IN PATIENTS WHO UNDERWENT OPEN ELECTIVE HEPATIC RESECTION BETWEEN NOVEMBER 2011 AND JULY 2014. THERE WERE A TOTAL OF 138 PATIENTS: THERE ARE 69 PATIENTS IN THE VESSEL SEALING DEVICE AND 69 IN THE STAPLER HEPATECTOMY GROUP. IN BOTH GROUPS, A UNIVERSAL ARTICULATING 45MM RELOAD WITH 2.5MM STAPLES WAS USED TO DIVIDE THE HEPATIC VEINS AND PORTAL TRIAD. COMPLICATIONS INCLUDED: 11 DEATHS (BOTH GROUPS). CAUSE OF DEATH WAS NOT REPORTED. ARTICLE: RANDOMIZED CLINICAL TRIAL OF STAPLER HEPATECTOMY VERSUS LIGASURE¿ TRANSECTION IN ELECTIVE HEPATIC RESECTION AUTHOR: J. FRITZMANN YEAR:2018 PUBLICATION: JOHN WILEY & SONS LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403637 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN 030454 10884523002850

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death