BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 15700848 · Received October 31, 2022

    Report

    Report Number
    3005075853-2022-07414
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    November 17, 2021
    Report Date
    October 31, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: ENDOSCOPIC VACUUM THERAPY IN SALVAGE AND STANDALONE TREATMENT OF GASTRIC LEAKS AFTER BARIATRIC SURGERY AUTHORS: AHRENS MARKUS1,2 · BECKMANN JAN HENRIK2 · REICHERT BENEDIKT2 · HENDRICKS ALEXANDER3 · BECKER THOMAS2 · SCHAFMAYER CLEMENS3 · EGBERTS JAN-HENDRIK4 CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2022); 407:1039¿1046. HTTPS://DOI.ORG/10.1007/S00423-021-02365-9. THIS SINGLE-CENTER RETROSPECTIVE STUDY IS TO REPORT ON THE TREATMENT OF 31 GASTRIC LEAKS (GL) THAT OCCURRED AFTER 1006 BARIATRIC OPERATIONS BETWEEN 2011 AND 2017. THE MOST PREVALENT PROCEDURES WERE SLEEVE GASTRECTOMIES (N = 521), PROXIMAL GASTRIC BYPASSES (RYGB, N = 441), AND MINI-GASTRIC BYPASSES (MGB, N = 12). FURTHER 32 PROCEDURES CONSTITUTED OTHER BARIATRIC OPERATIONS SUCH AS GASTRIC BANDING EXCISION (N = 11), BILIOPANCREATIC DIVERSION (BPD + DS, N = 2), SADI-OPERATIONS (N = 5), AND DISTAL GASTRIC BYPASSES (N = 14). THE MEAN BMI OF THE PATIENT COHORT WAS 50 (MIN = 36, MAX = 76) KG/M2. SG WAS PERFORMED WITH A 42 CHARRIER BOUGIE AND ROUTINE ADDITIONAL SERO-MUSCULAR SUTURING OF THE PROXIMAL STAPLE LINE. FOR RYGB AND MINI-GASTRIC BYPASS (MGB), GASTRO-JEJUNOSTOMY WAS PERFORMED AS A SIDE-TO-SIDE LINEAR STAPLER ANASTOMOSIS. IN ALL CASES, THE ECHELON FLEX¿ STAPLER (ETHICON, JOHNSON&JOHNSON), WITH GREEN AND GOLDEN MAGAZINES WITHOUT BUTTRESSING, WAS USED. REPORTED COMPLICATIONS INCLUDE GASTRIC LEAKS (N=31), THESE OCCURRED = 7 DAYS POSTOPERATIVE WHICH SHOWED AN INCREASE IN CRP (> 100 MG/DL) AS A FIRST SIGN (N=22), WHILE (N=9, INCLUDING A 68-YEAR-OLD PATIENT) OCCURRED > 7 DAYS POSTOPERATIVE AND MANIFESTED THEMSELVES THROUGH FEVER OR PAIN IN THE UPPER ABDOMEN AS FIRST SYMPTOMS AND CRP > 100 MG/DL IN THE FURTHER DIAGNOSTICS. IN CONCLUSION, EVT IS HIGHLY BENEFICIAL IN CASES OF GASTRIC LEAKS IN OBESITY SURGERY WHERE LOCAL PERITONITIS IS PRESENT. REVISIONAL SURGERY WAS UNSUCCESSFUL LATER THAN 2 DAYS AFTER PRIMARY SURGERY (16 OF 16 CASES). EVT SHOWS A SIMILAR HEALING RATE TO STENT THERAPY (80¿100%) BUT A SHORTER DURATION OF TREATMENT. THE ADVANTAGES OF EVT ARE ENDOSCOPIC ACCESS, INTERNAL DRAINAGE, RAPID GRANULATION, AND DIRECT THERAPY CONTROL. IN COMPARTMENTALIZED GASTRIC LEAKS, EVT WAS SUCCESSFUL AS A STANDALONE THERAPY WITHOUT EXTERNAL DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455841 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 Unknown Required Intervention