BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 7801737 · Received August 21, 2018

    Report

    Report Number
    3005075853-2018-12252
    Event Type
    Injury
    Date Received
    August 21, 2018
    Report Date
    July 25, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW KOF JOURNAL ARTICLE: THE RESULTS OF 100 ROBOTIC VERSUS 100 LAPAROSCOPIC GASTRIC BYPASS PROCEDURES: A SINGLE HIGH VOLUME CENTRE EXPERIENCE AUTHOR(S): R. M. SMEENK AND G. VAN ¿T HOF AND E. ELSTEN AND P. G. B. M. FESKENS CITATION: OBES SURG (2016) 26:1266¿1273; DOI 10.1007/S11695-015-1933-Y. THE PURPOSE OF THIS RETROSPECTIVE STUDY ANALYSIS WAS TO COMPARE THE RESULTS OF A FULLY ROBOTIC GASTRIC BYPASS (RGB) WITH THE STANDARD LAPAROSCOPIC GASTRIC BYPASS (LGB) IN A HIGH VOLUME AND EXPERIENCED CENTRE. FROM NOV2011 TO JAN2015, 100 RGB WERE COLLECTED. OF THESE, 92 WERE FEMALE WITH MEAN AGE OF 39 YEARS (RANGED 20-62 YEARS; SD OF 10.21 YEARS) AND MEAN BMI OF 40 (RANGED 35-47 SD OF 2.66). IN THE SAME PERIOD, 100 LGB WERE COLLECTED. OF THESE, 80% WERE FEMALE WITH MEAN AGE OF 42 YEARS (RANGED 18-65 YEARS; SD OF 11.87 YEARS) AND MEAN BMI OF 42 (RANGED 35-56; SD OF 4.75). IN THE PROCEDURE, THE BILIARY LIMB WAS CUT AT 70-80 CM FROM THE TREITZ LIGAMENT USING LINEAR ECHELON STAPLER LOADED WITH WHITE 60 MM CARTRIDGE. THE LESSER OMENTION WAS OPENED WITH HARMONIC ACE ULTRASONIC DEVICE. THE GASTRIC POUCH WAS CREATED USING LINEAR ECHELON STAPLER LOADED WITH BLUE 60 MM CARTRIDGE. THE ALIMENTARY LIMB IS BROUGHT TO THE TOP OF THE VERTICAL STAPLE LINE OF THE GASTRIC POUCH AND FIXED WITH AN ETHIBOND SUTURE IN ORDER TO PREVENT TENSION ON THE GASTROJEJUNAL ANASTOMOSIS. THE ANTECOLIC ANTIGASTRIC GASTROJEJUNOSTOMY WAS PERFORMED USING LINEAR ECHELON STAPLER LOADED WITH 60 MM BLUE CARTRIDGE. ETHIBOND WAS PUT THROUGH BOTH BOWEL LIMBS AND THE LIVER RETRACTOR IN ORDER TO LIFT THE TWO LIMBS TO FACILITATE THE CREATION OF THE ANASTOMOSIS. THE ENTEROENTEROSTOMY IS CREATED WITH THE LINEAR ECHELON STAPLER, LOADED WITH A WHITE 60 MM CARTRIDGE. IN RGB, POWERED ECHELON WAS USED. IN RGB, COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=1) THAT WAS STOPPED BY RELAPAROTOMY AND BLOOD TRANSFUSIONS, IATROGENIC STAPLE DEFECT AT THE BACK OF JEJUNOJEJUNOSTOMY (N=1) WHICH WAS REPAIRED BY RELAPAROSCOPY ON POSTOPERATIVE DAY 2, AND INTRA-ABDOMINAL BLEEDING (N=1) THAT COULD BE TREATED CONSERVATIVELY WITH BLOOD TRANSFUSION. IN LGB, COMPLICATION INCLUDED BILATERAL PNEUMONIA (N=1) TREATED WITH ANTIBIOTICS, BLOW-OUT OF THE STOMACH REMNANT (N=1) AS A RESULT OF OBSTRUCTION OF THE SMALL BOWEL ANASTOMOSIS BY A LARGE CLOT WHICH TREATED BY RELAPAROTOMY WHERE CLOT WAS REMOVED AND A PEG-CATHETER WAS PLACED IN THE STOMACH, AND FEVER AND ABDOMINAL PAIN (N=3) TREATED WITH BROAD-SPECTRUM ANTIBIOTICS. THE STAPLER DEFECT TYPICALLY ILLUSTRATES THE EFFECT OF THE LACK OF EXPERIENCE IN STAPLER HANDLING OF THE OPERATION ROOM ASSISTANTS. UNNOTICED, THE STAPLER DEVICE HAD PERFORATED THE DORSAL WALL OF THE AFFERENT ALIMENTARY LIMB. THE ROUX-EN-O BYPASS WAS THE OTHER UNLUCKY COMPLICATION IN THE BEGINNING OF THE LEARNING CURVE, CAUSED BY HARVESTING THE WRONG SMALL BOWEL LIMB. THIS WAS PROBABLY CAUSED BY UNCLEAR ANATOMY AS A RESULT OF ADHESIONS AT THE TREITZ LIGAMENT. IN THIS STUDY, A LEARNING CURVE WAS CONFIRMED BY A DECREASE OF SURGICAL TIME TO A PLATEAU AFTER 25 PROCEDURES. THE FULLY ROBOTIC GASTRIC BYPASS IS A FEASIBLE PROCEDURE WITH PROS AND CONS IN COMPARISON WITH THE LAPAROSCOPIC EQUIVALENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644037 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention