BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9558988 · Received January 7, 2020

    Report

    Report Number
    3005075853-2020-00106
    Event Type
    Injury
    Date Received
    January 7, 2020
    Report Date
    December 12, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2015. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE, TITLE : A COMPARATIVE RETROSPECTIVE STUDY OF ROBOTIC SLEEVE GASTRECTOMY VS ROBOTIC GASTRIC BYPASS. AUTHOR : RADOMIR KOSANOVIC, REY JESÚS ROMERO, CHARAN DONKOR ARMANDO SARASUA, JORGE RAFAEL RABAZA, ANTHONY MICHAEL GONZALEZ. CITATION: INT J MED ROBOTICS COMPUT ASSIST SURG 2015; 11: 275¿283. / DOI: 10.1002/RCS.1621. THE PURPOSE OF THIS COMPARATIVE RETROSPECTIVE STUDY FROM A SINGLE INSTITUTION WAS TO MATCH ROBOTIC GASTRIC BYPASS (RGB) VS ROBOTIC SLEEVE GASTRECTOMY (RSG) AND COMPARE THEM TO THOSE OBSERVED WITH THE LAPAROSCOPIC PLATFORM. FROM SEP 2009 TO MAY 2012, A TOTAL OF 299 PATIENTS UNDERWENT EITHER ROBOTIC GASTRIC BYPASS (RGB) (N=165) OR ROBOTIC SLEEVE GASTRECTOMY (RSG) (N=134). IN BOTH GROUPS, A MIDLINE SUPRA-UMBILICAL OR UMBILICAL VERTICAL INCISION WAS PERFORMED AND PNEUMOPERITONEUM (12¿15MMHG) WAS CREATED USING A VERESS NEEDLE OR AN OPTICAL TROCAR (ENDOPATH XCEL ETHICON). DURING RGB, THE LAPAROSCOPICALLY STITCH-MARKED BILIOPANCREATIC LIMB WAS TRANSECTED WITH A LINEAR STAPLER (ECHELON ENDOPATH, ETHICON ENDOSURGERY) LOADED WITH A WHITE CARTRIDGE (45MM) THROUGH THE ASSISTANT PORT, LEAVING THE STITCH ON THE ALIMENTARY LIMB. THE INTERNAL PART OF THE JEJUNO¿JEJUNAL ANASTOMOSIS BETWEEN THE ALIMENTARY AND BILIOPANCREATIC LIMBS WAS CREATED USING A WHITE CARTRIDGE, THEN THE ENTEROTOMY WAS CLOSED WITH WHITE RELOADS AND REINFORCED WITH ONE LAYER OF RUNNING SUTURE (VYCRIL 2-0). THE LESSER OMENTUM WAS OPENED AND THE RETROGASTRIC SPACE ENTERED FOR TRANSECTION ACROSS THE STOMACH, 3¿4 CM DISTALLY FROM THE GASTROESOPHAGEAL JUNCTION, USING ONE HORIZONTAL APPLICATION WITH A 45MM STAPLER (BLUE). CLOSURE OF THE ENTEROTOMY IN PERFORMED WITH TWO LAYERS OF 2-0 VICRYL SUTURES IN A RUNNING FASHION. REINFORCEMENT TO THE STAPLE LINE WAS DONE EITHER BY BIOABSORBABLE MATERIAL (PERI-STRIPS DRY) OR FIBRIN GLUE APPLICATION (EVICEL FIBRIN SEALANT, ETHICON). FOR RSG, THE GREATER CURVATURE OF THE STOMACH WAS DIVIDED, IN MOST OF THE CASES WITH THE USE OF A HARMONIC SCALPEL (ETHICON ENDO-SURGERY) OR, MORE RECENTLY, WITH USE OF AN ENDOWRIST ONE VESSEL SEALER. RESECTION OF THE STOMACH WAS STARTED 4¿6 CM FROM THE PYLORUS, WITH SEQUENTIAL TRANSECTIONS USING A LINEAR STAPLER (ECHELON ENDOPATH, ETHICON ENDO-SURGERY) THROUGH THE ASSISTANT PORT. FOR THE FIRST TWO OR THREE APPLICATIONS IN THE ANTRAL AREA, GREEN CARTRIDGES (45MM) WERE UTILIZED, THEN BLUE (45MM) FOR THE THREE OR FOUR REMAINING TRANSECTIONS TO REACH THE ANGLE OF HIS. THE ANAESTHESIOLOGIST WAS POSITIONED OVER THE LEFT SIDE OF THE PATIENT¿S HEAD AND FROM THIS POSITION HE MANAGED A 38-FR BOUGIE (GASTRIC CALIBRATION TUBE, ETHICON) IN THE STOMACH. THE STAPLE LINE WAS REINFORCED WITH OVERSEWING PLUS FIBRIN GLUE (EVICEL FIBRIN SEALANT, ETHICON), OVERSEWN ALONE IN, AND BIOABSORBABLE-BUTTRESSED MATERIAL (PERI-STRIPS DRY). POSTOPERATIVE COMPLICATIONS UNDER RGB GROUP INCLUDED BLEEDING (N=2) ONE REQUIRED BLOOD TRANSFUSION, AND A HAEMATOMA REQUIRED PERCUTANEOUS DRAINAGE; AND INTRAABDOMINAL ABSCESS (N=1) TREATED WITH ANTIBIOTICS AND OBSERVATION; SMALL BOWEL PERFORATION (N=1) NEEDED REOPERATION; TREATED WITH BOWEL RESECTION AND SIDE-TO-SIDE ANASTOMOSIS AND DISCHARGED 12 DAYS LATER; INCARCERATED HERNIAS IN TROCAR SITES (N=1) AND INCISIONAL HERNIA (N=1). POSTOPERATIVE COMPLICATIONS UNDER RSG GROUP INCLUDED SUPERIOR MESENTERIC VEIN THROMBOSIS (N=1) TREATED WITH ANTICOAGULATION; BLEEDING FROM STAPLE LINE (N=1) REQUIRED REOPERATION; AND STOMACH TORSION (N=1) INITIALLY REQUIRED DILATATIONS, THEN EVENTUALLY DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS AND GASTROPEXY. RSGS HAD SHORTER SURGICAL TIMES AND A LOWER INCIDENCE OF LONGTERM COMPLICATIONS WHEN COMPARED WITH RGBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21599 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other