BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 15707698 · Received November 1, 2022

    Report

    Report Number
    3005075853-2022-07447
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    January 13, 2021
    Report Date
    November 1, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION DATE 2021, EXACT EVENT DATE UNK. BATCH # UNK. 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 RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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

    TITLE: MINIMALLY INVASIVE DISTAL PANCREATECTOMY: A CASE-MATCHED COST-ANALYSIS BETWEEN ROBOT-ASSISTED SURGERY AND DIRECT MANUAL LAPAROSCOPY. AUTHORS: GREGORIO DI FRANCO, ANDREA PERI, VALENTINA LORENZONI, MATTEO PALMERI, NICCOLÒ FURBETTA, SIMONE GUADAGNI, DESIRÉE GIANARDI, MATTEO BIANCHINI, LUCA EMANUELE POLLINA,· FRANCA MELFI, DOMENICA MAMONE, CARLO MILLI, GIULIO DI CANDIO,· GIUSEPPE TURCHETTI, ANDREA PIETRABISSA,· LUCA MORELLI. CITATION: SURGICAL ENDOSCOPY (2022) 36:651¿662 HTTPS://DOI.ORG/10.1007/S00464-021-08332-1. THE AIM OF THE PRESENT STUDY IS TO ADDRESS THIS ISSUE BY COMPARING SURGICAL OUTCOMES AND COSTS OF RDP AND LAPAROSCOPIC DISTAL PANCREATECTOMIES (LDP). BETWEEN JANUARY 2008 AND JANUARY 2020, 47 LDPS AND 88 RDPS WERE PERFORMED. FOR THE LDP GROUP, THE SUPERIOR AND INFERIOR BORDERS OF THE PANCREAS ARE DEFINED AND THE PANCREAS IS TRANSECTED USING A STAPLER (ETS FLEX 45 ENDOSCOPIC ARTICULATING STAPLE, JOHNSON & JOHNSON, USA). PROLENE SUTURES WERE ALSO USED FOR ALL GROUPS. LDP: (B)(4) POST-OPERATIVE PANCREATIC FISTULA. (B)(4) CLAVIEN¿DINDO SCORE = III. (B)(4) BIOCHEMICAL LEAK. SI-RDP: (B)(4) POST-OPERATIVE PANCREATIC FISTULA. (B)(4) CLAVIEN¿DINDO SCORE = III. XI-RDP: (B)(4) POST-OPERATIVE PANCREATIC FISTULA. (B)(4) CLAVIEN¿DINDO SCORE = III. RAS IS MORE EXPENSIVE THAN DML FOR DP BECAUSE OF HIGHER ACQUISITION AND MAINTENANCE COSTS. THE FLATTENING OF THESE DIFFERENCES CONSIDERING ONLY THE VARIABLE COSTS, IN A HIGH-VOLUME MULTIDISCIPLINARY CENTER FOR RAS, SUGGESTS A POSSIBLE OPTIMIZATION OF THE COSTS IN THIS SETTING. RAS MIGHT BE PARTICULARLY INDICATED FOR MINIMALLY INVASIVE DP WHEN THE SPLEEN PRESERVATION IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484072 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. ATS45 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention