BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9359226 · Received November 21, 2019

    Report

    Report Number
    3005075853-2019-23676
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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

    (B)(4). DATE SENT: 11/21/2019. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    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
    1146390 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE