BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH

    MDR report key: 6988432 · Received October 30, 2017

    Report

    Report Number
    3005075853-2017-05783
    Event Type
    Injury
    Date Received
    October 30, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BELIEVE THAT THE POST-OPERATIVE ISSUES NOTED IN THE JOURNAL ARTICLE WERE DIRECTLY RELATED TO AN ALLEGED DEFICIENCY WITH AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REVIEW OF JOURNAL ARTICLE: MINIMIZING HEMORRHAGIC COMPLICATIONS IN LAPAROSCOPIC SLEEVE GASTRECTOMY - A RANDOMIZED CONTROLLED TRIAL AUTHORS: GIDEON SROKA, DARIA MILEVSKI, DAN SHTEINBERG, HUSAM MADY, IBRAHIM MATTER CITATION: OBES SURG (2015) 25:1577¿1583. DOI 10.1007/S11695-015-1580-3. THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL IS TO EXAMINE THE AUTHORS¿ HYPOTHESIS THAT STAPLE LINE BLEEDING STARTS IN THE POST-ANESTHESIA CARE UNIT (PACU) DUE TO A RISE IN BLOOD PRESSURE AND THAT ACTIVE ELEVATION OF BLOOD PRESSURE WHILE PERFORMING HEMOSTASIS CAN REDUCE THE INCIDENCE OF POSTOPERATIVE BLEEDING. THIS STUDY IS ALSO TO ASSESS THE ADDED VALUE OF FIBRIN GLUE, AND SUTURING, ON HEMOSTATIC CONTROL IN LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). BETWEEN FEBRUARY 2013 AND MARCH 2014, 165 PATIENTS ADMITTED FOR LSG WERE RANDOMLY ASSIGNED TO ONE OF 3 ARMS: STAPLER LINE APPLICATION OF BIOLOGIC GLUE ¿ EVICEL (E: N=49; 35 FEMALE, 14 MALE; MEAN AGE 39.6+/-10.15 YEARS; MEAN BMI 43.11+/-5.87 KG/M2); CONTINUOUS OVER SUTURE OF THE STAPLER LINE USING 3-0 PDS (S: N=49; 34 FEMALE, 15 MALE; MEAN AGE 35.9+/-11.6 YEARS; MEAN BMI 42.13+/-4.46 KG/M2), OR CONTROL (C: N=67; 43 FEMALE, 24 MALE; MEAN AGE 38.5+/-12.6; MEAN BMI 43.82+/-5.32 KG/M2). ECHELON FLEX 60MM WITH CHANGING STAPLE HEIGHT FROM BLACK TO BLUE LOADS ACCORDING TO THE THICKNESS OF THE STOMACH WALL WAS USED IN ALL PROCEDURES. EVENTS INCLUDE: HEMORRHAGIC COMPLICATIONS [E: N=3 (2 RECEIVED PACKED CELLS); C: N=8 (1 RECEIVED PACKED CELLS)], INFECTED HEMATOMA [E: N=1 (READMITTED, TREATED WITH ANTIBIOTICS); C: N=2 (READMITTED, TREATED WITH ANTIBIOTICS AND CT-GUIDED DRAINAGE)], AND LEAK [S: N=1; C: N=1; BOTH TREATED WITH CT-GUIDED DRAINAGE AND LONG-TERM ANTIBIOTICS]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766106 ECHELON ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention