BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 15933721 · Received December 7, 2022

    Report

    Report Number
    1219930-2022-04782
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    February 14, 2022
    Report Date
    December 7, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884523003250
    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 PRODUCTS: EGIA60AXT EGIA60 ARTIC EXTRA THICKSULU (LOT#: UNKNOWN); UNKNOWN ENDO GIA INSTRUMENT (LOT#: UNKNOWN) ARTICLE: ROBOTIC VERSUS OPEN PANCREATIC SURGERY: A PROPENSITY SCORE-MATCHED COST-EFFECTIVENESS ANALYSIS SOURCE: SPRINGERLINK AND PUBMED. LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:1923¿1933, HTTPS://DOI.ORG/10.1007/S00423-022-02471-2 RECEIVED: 5 OCTOBER 2021 / ACCEPTED: 14 FEBRUARY 2022. 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 LITERATURE, A RETROSPECTIVE STUDY AIMED TO COMPARE PATIENTS UNDERGOING OPEN PANCREATIC SURGERY AND ROBOTIC PANCREATIC SURGERY WITH REGARDS TO COST-EFFECTIVENESS BETWEEN 2017 AND 2019. THE STUDY INCLUDED ALL PATIENTS WHO UNDERWENT OPEN OR ROBOTIC PARTIAL PANCREATICODUODENECTOMY, DISTAL PANCREATECTOMY, OR TOTAL PANCREATECTOMY. FOR DISTAL PANCREATECTOMY, CLOSURE OF THE PANCREATIC REMNANT WAS EITHER PERFORMED USING A 60-MM BLACK RELOAD OR ANOTHER TECHNIQUE. FOR OPEN PANCREATIC SURGERY, THE PANCREAS WAS DISSECTED BY ELECTROCAUTERY OR A 60-MM BLACK RELOAD. 282 PATIENTS UNDERWENT OPEN SURGERY AND 92 PATIENTS UNDERWENT ROBOTIC SURGERY. POSTOPERATIVE COMPLICATIONS INCLUDED: POSTOPERATIVE PANCREATIC FISTULA AND POSTOPERATIVE PANCREATIC HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469929 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AXT 20884523003250

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention