BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12268043 · Received August 3, 2021

    Report

    Report Number
    3005075853-2021-04373
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    August 6, 2020
    Report Date
    July 5, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION DATE (B)(6) 2020. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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 · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: ONE ANASTOMOSIS GASTRIC BYPASS VS. ROUX-EN-Y GASTRIC BYPASS: A 5-YEAR FOLLOW-UP PROSPECTIVE RANDOMIZED TRIAL AUTHORS: LUIS LEVEL, ALEJANDRO ROJAS, SILVIA PIÑANGO, YUBISAY AVARIANO CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2021); 406: 171¿179. DOI: HTTPS://DOI.ORG/10.1007/S00423-020-01949-1. THE OBJECTIVE OF THIS PROSPECTIVE, COMPARATIVE, AND RANDOMIZED STUDY WAS TO COMPARE THE OUTCOMES OF A RELATIVELY NOVEL TECHNIQUE OAGB WITH RYGB IN TERMS OF COMPLICATIONS, PERCENT OF EXCESS WEIGHT LOST (%EWL), RESOLUTION OF COMORBIDITIES, OPERATIVE TIME, USE OF STAPLING RELOADS, POSTOPERATIVE PAIN, AND HOSPITAL STAY. BETWEEN AUGUST 2012 TO JULY 2013, A TOTAL OF 28 FEMALE PATIENTS WHO MET THE INCLUSION CRITERIA UNDERWENT BARIATRIC SURGERY. THESE PATIENTS WERE RANDOMLY ASSIGNED (1:2) TO TWO GROUPS: 9 PATIENTS (MEAN AGE = 37.5 ± 6.6 YEARS; BMI = 42.9 ± 5.5) FOR OAGB AND 19 PATIENTS (MEAN AGE = 36.8 ± 9.3 YEARS; BMI = 42.6 ± 5.9) FOR RYGB. THE STAPLING MATERIAL USED FOR ALL PROCEDURES WAS ECHELON (ETHICON) 60 AND 45 LINEAR STAPLER; 60 MM BLUE CARTRIDGES FOR GASTRIC POUCH; 45 MM WHITE CARTRIDGES FOR GJ ANASTOMOSIS; AND 45 MM WHITE CARTRIDGES FOR JJ ANASTOMOSIS AND EXCLUSION OF BILIOPANCREATIC LIMB. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE PAIN WITH VAS LEVEL 3 TO 8 (N=28); ABDOMINAL DISTENSION AND POSTOPERATIVE ILEUS (N=2) WHICH IMPROVED WITH MEDICAL TREATMENT. IN CONCLUSION, AT 5-YEAR FOLLOW-UP, PATIENTS OF BOTH TECHNIQUES ACHIEVED SIMILAR OUTCOMES IN TERMS OF %EWL AND RESOLUTION OF COMORBIDITIES, WITHOUT EARLY OR MID-TERM MAJOR COMPLICATIONS AND NO MORTALITY. OAGB DEMONSTRATED LESS USE OF SURGICAL STAPLING AND UNEXPLAINABLY LESS POSTOPERATIVE PAIN COMPARED TO RYGB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162328 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1