BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 10275987 · Received July 15, 2020

    Report

    Report Number
    3005075853-2020-03573
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H1: MDR DECISION: NOT REPORTABLE. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. DEAR SIR/MADAME, I DO NOT BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT: (B)(6) 2020. SEE ATTACHED JOURNAL ARTICLE. - ATTACHMENT: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE UNK. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PREOPERATIVE ADMINISTRATION OF OMEGA-3 FATTY ACIDS ON POSTOPERATIVE PAIN AND ACUTE-PHASE REACTANTS IN PATIENTS UNDERGOING ROUX-EN-Y GASTRIC BYPASS: A RANDOMIZED CLINICAL TRIAL. AUTHORS: JAIME RUIZ-TOVAR, MARIA BLANCA, ALEJANDRO GARCIA, JUAN GONZALEZ, SONSOLES GUTIERREZ, AMALIA PANIAGUA, MARIA JOSE PRIETO, LUISA RAMALLO, LUCIA LLANOS, MANUEL DURAN. CITATION: CLINICAL NUTRITION. 2019; 38: 1588E1593. DOI: HTTPS://DOI.ORG/10.1016/J.CLNU.2018.07.026. THE TERM ¿IMMUNONUTRITION¿ (IMN) DESCRIBES THE ENTERAL ADMINISTRATION OF CERTAIN SUBSTRATES WITH A THEORETICAL IMMUNOMODULATING FUNCTION. FROM ALL THE ELEMENTS CONFORMING THESE IMN FORMULAS, OMEGA-3 FATTY ACIDS (O3FA) ARE HYPOTHESIZED TO BE THE MOST IMPORTANT COMPONENT FOR IMMUNOMODULATION, WITH INCREASED ANTI-INFLAMMATORY AND ANTIOXIDANT EFFECT. THIS IS A PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF 40 PATIENTS (25 FEMALE AND 15 MALE PATIENTS; AGE RANGE: 26 TO 64 YEARS OLD) UNDERGOING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. PATIENTS WERE RANDOMLY ASSIGNED INTO 2 GROUPS: THOSE PATIENTS RECEIVING A PREOPERATIVE BALANCED ENERGY HIGH-PROTEIN FORMULA (CONTROL GROUP) AND THOSE ONES WHO RECEIVED THE SAME PREOPERATIVE NUTRITIONAL FORMULA ENRICHED WITH O3FA (EXPERIMENTAL GROUP). DURING THE SURGICAL PROCEDURE IN BOTH GROUPS, A 6-CM LONG GASTRIC POUCH WAS PERFORMED, CALIBRATING IT WITH A 36-FR BOUGIE, WITH AN ECHELON FLEX LINEAR STAPLER (ETHICON). BOTH ANASTOMOSES WERE PERFORMED WITH ECHELON FLEX LINEAR STAPLER (ETHICON), CALIBRATING THE GASTROJEJUNAL ANASTOMOSIS TO 2 CM. IN BOTH GROUPS, REPORTED COMPLICATIONS INCLUDED GASTRO-JEJUNAL LEAK (N-1) REQUIRING REOPERATION, SUTURE OF THE PERFORATION, LAVAGE, AND DRAIN PLACEMENT ADJACENT TO THE GASTRO-JEJUNAL ANASTOMOSIS. THE PATIENT RECOVERED UNEVENTFULLY AFTER THE REOPERATION. ONE OF THE OBJECTIVES OF THE STUDY WAS TO MAXIMIZE THE REDUCTION OF WEIGHT PREOPERATIVELY, WHICH HAS DEMONSTRATED TO BE BENEFICIAL. THIS WEIGHT LOSS IS HELPFUL FOR THE SURGEON, SINCE A REDUCTION OF HEPATOMEGALIA SECONDARY TO STEATOSIS IS ACHIEVED. THE USE OF NUTRITIONAL SUPPLEMENTS ENRICHED WITH O3FA IS ASSOCIATED WITH A GREATER PRE-OPERATIVE WEIGHT LOSS, REDUCES POST-OPERATIVE PAIN AND DECREASES POST-OPERATIVE LEVELS OF C REACTIVE PROTEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738583 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention