BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 12283421 · Received August 5, 2021

    Report

    Report Number
    3005075853-2021-04511
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    October 8, 2019
    Report Date
    July 7, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019. 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?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLETITLE: SHORT-TERM OUTCOMES OF SINGLE-PORT VERSUS CONVENTIONAL LAPAROSCOPIC SLEEVE GASTRECTOMY: A PROPENSITY SCORE MATCHED ANALYSIS AUTHORS: HADRIEN TRANCHART, LIONEL REBIBO, MARTIN GAILLARD, ABDENNACEUR DHAHRI, PANAGIOTIS LAINAS, JEAN-MARC REGIMBEAU, IBRAHIM DAGHER, CITATION: SURGICAL ENDOSCOPY (2020); 34:3978¿3985. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07175-1. THE AIM OF THIS RETROSPECTIVE PROPENSITY SCORE MATCHED STUDY IN A PROSPECTIVELY COLLECTED DATA WAS TO COMPARE THE SHORT-TERM OUTCOMES OF SPSG VERSUS CONVENTIONAL LAPAROSCOPIC SLEEVE GASTRECTOMY (CLSG) WITH REGARDS TO MORBIDITY, WEIGHT LOSS, AND CO-MORBIDITY RESOLUTION. BETWEEN JANUARY 2015 AND DECEMBER 2016, A TOTAL OF 1122 PATIENTS UNDERWENT SLEEVE GASTRECTOMY (SG), CONSISTING OF 610 PATIENTS (101 MALE AND 509 FEMALE; WITH MEDIAN AGE OF 42 (33¿51) YEARS; MEDIAN BMI OF 42.2 (31.3¿45.9) KG/M2) IN SINGLE-PORT SLEEVE GASTRECTOMY (SPSG) AND 512 PATIENTS (135 MALE AND 377 FEMALE; MEDIAN AGE OF 41 (32¿49) YEARS; MEDIAN BMI OF 43.7 (40.2¿48.7) KG/M2) IN CONVENTIONAL LAPAROSCOPIC SLEEVE GASTRECTOMY (CLSG). IN THE SPSG PROCEDURE, TRANSECTION OF THE STOMACH WAS DONE USING A 60-MM ENDOSCOPIC STAPLER (ECHELON FLEX POWERED WITH GOLD CARTRIDGE, ETHICON, OR A COMPETITOR DEVICE) AFTER PLACEMENT OF A 36-FR OROGASTRIC CALIBRATION TUBE. REPORTED COMPLICATIONS INCLUDED 90-DAY POSTOPERATIVE COMPLICATION/MORBIDITY (N=?); INTRA-ABDOMINAL OR INTRALUMINAL BLEEDING (N=?); STAPLE-LINE LEAK (N=?) TREATED BY SURGICAL AND/OR ENDOSCOPIC AND/OR RADIOLOGIC APPROACH UNDER GENERAL ANESTHESIA (IIIB); DINDO¿CLAVIEN GRADE = IIIA (N=?); POSTOPERATIVE HEMATOMA (N=?) TREATED BY PERCUTANEOUS DRAINAGE UNDER LOCAL ANESTHESIA (IIIA) OR BY SURGICAL AND/OR ENDOSCOPIC AND/OR RADIOLOGIC APPROACH UNDER GENERAL ANESTHESIA (IIIB); AND INCISIONAL HERNIA (N=?). IN CONCLUSION, THE PRESENT COMPARATIVE SERIES SUPPORTS THAT SPSG CAN BE PERFORMED SAFELY WITH SIMILAR INTRAOPERATIVE AND POSTOPERATIVE MORBIDITY COMPARED TO THE CLSG. WEIGHT LOSS AND COMORBIDITIES RESOLUTION AT 6 MONTHS AND 1 YEAR ARE EQUIVALENT. A 15-MIN LONGER OPERATIVE DURATION IN THE SPSG GROUP WAS THE ONLY NEGATIVE SIDE OF AN APPROACH THAT POTENTIALLY IMPROVES THE COSMETIC RESULTS IN A POPULATION OF PATIENTS PARTICULARLY CONCERNED BY ESTHETICAL IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177988 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