BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 29MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 21490366 · Received February 28, 2025

    Report

    Report Number
    3005075853-2025-01578
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 25, 2023
    Report Date
    February 28, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 2/27/2025 D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ROBOTIC-ASSISTED IVOR LEWIS ESOPHAGECTOMY IS SAFE AND COST EQUIVALENT COMPARED TO MINIMALLY INVASIVE ESOPHAGECTOMY IN A TERTIARY REFERRAL CENTER AUTHOR: SEBASTIAN KNITTER 1,*F>, MAX M. MAURER 1,2, AXEL WINTER 1, EVA M. DOBRINDT 11>, PHILIPPASEIKA 1, PAUL V. RITSCHL 11>, JONAS. RAAKOW 11>, JOHANN PRATSCHKE 1 AND CHRISTIAN DENECKE 1 CITATION: HTTPS: / / DOI.ORG /10.3390 I CANCERS16010112. THIS IS A RETROSPECTIVE SINGLE-CENTER STUDY, THE PURPOSE WAS TO COMPARE POSTOPERATIVE OUTCOMES AND FINANCIAL EXPENSES BETWEEN 2017 AND 2021 IVOR LEWIS RAMIE AND MIE FOR EC/GEJ SETTING. FURTHERMORE, AIMED TO IDENTIFY COST DRIVERS AMONG PATIENT-RELATED AND PERIOPERATIVE PARAMETERS. THE COMPARISON BETWEEN RAMIE AND MIE HAVE DEMONSTRATED COMPARABLE SHORT- AND LONG TERM. OUTCOMES BETWEEN THE TWO APPROACHES. HOWEVER, CONCERNS REGARDING THE ADDED FINANCIAL BURDEN AND COST-EFFECTIVENESS OF RS, DUE TO HIGH ACQUISITION AND MAINTENANCE COSTS HAVE. PATIENTS WERE EXCLUDED IF THEY UNDERWENT OTHER SIMULTANEOUS SURGICAL PROCEDURES, IF SURGERY WAS PALLIATIVE, OR IF THEY WERE UNDER THE AGE OF 18 YEARS AT THE TIME OF RESECTION. PATIENTS WERE STRATIFIED INTO RAMIE OR MIE GROUPS BASED ON THE SURGICAL APPROACH, WHICH WAS DETERMINED ON A CASE-BY-CASE BASIS CONSIDERING PATIENT WISH, PATIENT CHARACTERISTICS SUCH AS BODY-MASS INDEX (BMI), PREVIOUS ABDOMINAL SURGERIES, OR ON THE SURGEON'S DISCRETION. WE ALSO HAD TO ADHERE TO THE ROBOT'S AVAILABILITY AS IT IS SHARED BY MULTIPLE SURGICAL TEAMS. POSTOPERATIVE OVERALL MORBIDITY WAS 38% AND 54% FOR RAMIE AND MIE, RESPECTIVELY. IN FINANCIAL TERMS, WHILE TOTAL COSTS AND DAILY COSTS PER STAY WERE COMPARABLE BETWEEN RAMIE AND MIE, RAMIE WAS ASSOCIATED WITH HIGHER COSTS FOR SURGERY. MULTIVARIATE ANALYSIS IDENTIFIED READMISSION TO THE ICU, EXTENDED HOSPITAL STAY, AL, AND PP AS FACTORS DRIVING INCREASED COSTS FOR ALL PATIENTS. ONE-YEAR QUALITY OF LIFE WAS BETTER AFTER MIE, WITH COMPARABLE THREE-YEAR OVERALL AND DISEASE-FREE SURVIVAL RATES BETWEEN MIE AND OE [28,29].NO SIGNIFICANT DIFFERENCES IN TOTAL AND DAILY COSTS PER STAY WERE FOUND BETWEEN RAMIE AND MIE. 60 MM ECHELON¿ POWERED GST LINEAR STAPLER (ETHICON INC., RARITAN, NJ, USA)WAS USED DURING 4-5 CM WIDE GASTRIC TUBE WAS CREATED CIRCULAR 29 MM ECHELON¿POWERED 30 STAPLER (ETHICON INC., RARITAN, NJ, USA) WHICH WAS USED WHEN ANASTOMOSIS WAS CREATEDREPORTED COMPLICATION: CIRCULAR 29 MM ECHELON¿POWERED 30 STAPLER (ETHICON INC., RARITAN, NJ, USA) -ANASTOMOTIC LEAK(N=17) TREATMENT: DIAGNOSED VIA ENDOSCOPY WHEN CLINICALLY SUSPECTED (FEVER, ELEVATED INFECTIOUS SERUM PARAMETERS) OR RADIOLOGICALLY THROUGH COMPUTER TOMOGRAPHY (CT) SCANS. IN CONCLUSIONS, RAMIE FOR EC/GEJ IS ASSOCIATED WITH IMPROVED POSTOPERATIVE OUTCOMES COMPARED TO MIE. FROM AN ECONOMIC POINT OF VIEW, THE FINANCIAL BURDEN BETWEEN RAMIE AND MIE IS COMPARABLE. HENCE, RAMIE MAY BE CONSIDERED A VALID ALTERNATIVE APPROACH FOR ESOPHAGECTOMY. HOWEVER, ADDITIONAL STUDIES CONDUCTED IN SPECIALIZED HIGH-VOLUME CENTERS ARE NECESSARY TO EVALUATE THE COST-EFFECTIVENESS OF BOTH APPROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810098 PWRD 29MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention