BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9361622 · Received November 22, 2019

    Report

    Report Number
    3005075853-2019-23690
    Event Type
    Injury
    Date Received
    November 22, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. NO.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE UNK. BATCH # UNK. 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. ADDITIONAL INFORMATION REQUEST TO THE AUTHOR: 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: SHORT-TERM RESULTS OF LAPAROSCOPIC SLEEVE GASTRECTOMY IN COMBINATION WITH HIATAL HERNIA REPAIR: EXPERIENCE IN A SINGLE ACCREDITED CENTER. AUTHORS: MAHER EL CHAAR, GEORGE EZEJI, LEONARDO CLAROS, MAUREEN MILETICS, JILL STOLTZFUS CITATION: OBES SURG (2016); 26:68¿76. DOI 10.1007/S11695-015-1739-Y. THE OBJECTIVE OF THIS EXPLORATORY STUDY IS TO INVESTIGATE THE INCIDENCE AND THE TYPE OF HIATAL HERNIA (HH) REPAIR DURING SLEEVE GASTRECTOMY (SG) IN ADDITION TO THE EFFECT OF HH REPAIR ON WEIGHT LOSS AND THE DEVELOPMENT OF GERD-RELATED SYMPTOMS FOLLOWING SG IN THE SHORT TERM FOLLOWING SURGERY. THIS RETROSPECTIVE REVIEW INCLUDES PROSPECTIVELY COLLECTED DATA OF 338 PATIENTS WHO UNDERWENT A PRIMARY SG BETWEEN SEPTEMBER 2009 AND DECEMBER 2012. OF THE 338 PATIENTS, 239 PATIENTS (54 MALE AND 185 FEMALE; MEAN AGE: 43.9±11.9; MEAN BMI: 45.1±6.4) UNDERWENT SG ALONE, 56 PATIENTS (12 MALE AND 44 FEMALE; MEAN AGE: 48.1±10.2; MEAN BMI: 42.6±5.9) UNDERWENT SG + HH, AND 43 PATIENTS(6 MALE AND 37 FEMALE; MEAN AGE: 49.2±9.1; MEAN BMI: 43.5±5.7) UNDERWENT SG + PARAESOPHAGEAL HERNIA (PEH) REPAIR. DURING THE SG PROCEDURE, THE GASTROHEPATIC LIGAMENT WAS TRANSECTED WITH AN ENERGY DEVICE (HARMONIC ACE; ETHICON) STARTING 4¿6 CM FROM THE PYLORUS. THE FUNDUS WAS COMPLETELY MOBILIZED AFTER TRANSECTING THE SHORT GASTRIC VESSELS UNTIL THE LEFT CRUS WAS IDENTIFIED. AFTER TAKING THE GASTROSPLENIC LIGAMENT DOWN AND MOBILIZING THE FUNDUS, A 36 FR BOUGIE WAS PLACED BY THE ANESTHESIOLOGIST AND LEFT IN PLACE DURING THE TRANSECTION OF THE GREATER CURVATURE OF THE STOMACH. THE GREATER CURVATURE OF THE STOMACH WAS TRANSECTED USING AN ECHELON STAPLER (ETHICON). DURING A POSTERIOR HERNIA REPAIR AND WHEN A MESH WAS USED FOR REINFORCEMENT, THE MESH LEAFLETS AROUND THE ESOPHAGUS WAS SECURED TO THE DIAPHRAGM USING FIBRIN SEALANT (EVICEL; ETHICON). REPORTED COMPLICATION IN THE SG + PEH GROUP INCLUDED INTRAABDOMINAL HEMORRHAGE (N-1) IN WHICH THE PATIENT UNDERWENT REEXPLORATION. IN CONCLUSION, PATIENTS WHO UNDERWENT SG IN COMBINATION WITH A HH REPAIR EXPERIENCED IMPROVEMENT IN SELF REPORTED GERD SYMPTOMS AND EXPRESSED A HIGH RATE OF POSTOPERATIVE SATISFACTION COMPARED TO PATIENTS UNDERGOING SG ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160338 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention