BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 20533912 · Received October 25, 2024

    Report

    Report Number
    3005075853-2024-08111
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    March 8, 2024
    Report Date
    October 25, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/25/2024. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, AND 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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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: REINFORCEMENT IN LAPAROSCOPIC SLEEVE GASTRECTOMY: IS IT EFFECTIVE? AUTHORS: MUMIN CO:JKUN, MD, TEVFIK K1VZLC1M UPRAK, MD, OMER GIINAL MD, AYGUN ALIYEVA, MD, AND ASZM CINGI MD. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2024;00:000-000. DOI: 10.1097/SLE.0000000000001283. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EXAMINE THE STAPLER LINE REINFORCEMENT AND ITS ASSOCIATION WITH POSTOPERATIVE LEAKAGE AND BLEEDING RATES. BETWEEN JANUARY 2011 AND OCTOBER 2018, A TOTAL OF 510 PATIENTS (384 FEMALE AND 126 MALE) WHO UNDERWENT SLEEVE GASTRECTOMY WERE INCLUDED IN THE STUDY. THE PATIENTS' MEAN AGE WAS 39.2 ± 10.5 YEARS, AND THE MEAN BMI WAS 48.4 ± 6.9 KG/M2. THEY WERE DIVIDED INTO 2 GROUPS ACCORDING TO WHETHER REINFORCEMENT OF THE STAPLE LINE WITH RUNNING IMBRICATING SUTURES WAS PERFORMED. THERE WERE 286 PATIENTS IN THE REINFORCEMENT GROUP AND 224 IN THE NONREINFORCEMENT GROUP. DISSECTION ALONG THE GREATER CURVATURE STARTED 3 TO 4 CM FROM THE PYLORUS AND PROCEEDED TOWARD THE LEFT CRUS. A HARMONIC SCALPEL (ETHICON ENDO-SURGERY, JOHNSON & JOHNSON) AND LIGASURE (VALLEYLAB HEALTHCARE GROUP LP) WERE USED FOR THIS PROCESS. THE RESECTIONS WERE PERFORMED USING ECHELON FLEX ENDOPATH RELOAD (GREEN, BLUE; ETHICON INC.) OR ENDO GIA RELOAD (GREEN, BLUE; MEDTRONIC INC.) LINEAR STAPLERS WITH 60-MM-LONG CARTRIDGES. THE STAPLER LINE WAS ALWAYS REINFORCED WITH A RUNNING IMBRICATING SUTURE (V-LOC ABSORBABLE WOUND CLOSURE DEVICE 2.0; COVIDIEN). THE RESECTION SURFACE WAS ALSO COVERED WITH FIBRIN SEALANT (TISSEEL; BAXTER HEALTHCARE CORP.) IN BOTH GROUPS OF PATIENTS. REPORTED COMPLICATIONS INCLUDE (N=?) DEATH DUE TO LEAK, (N=?) LEAK, (N=?) STAPLE LINE BLEEDING, (N=?) PARTIAL MIGRATION OF THE SLEEVE SEGMENT TO THE THORAX CAVITY, WHICH LED TO PARTIAL OBSTRUCTION, AND (N=?) ANY COMPLICATIONS UNSPECIFIED. IN CONCLUSION, THIS STUDY SHOWS THAT REINFORCEMENT WITH CONTINUOUS IMBRICATING SUTURES IS ASSOCIATED WITH LESS STAPLER LINE LEAKAGE AND A LOWER REOPERATION RATE AT THE COST OF INCREASED OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093111 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other