BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3871440 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03965
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL QUESTIONS ASKED BUT NO ANSWERS RECEIVED: HAVE THESE COMPLAINTS BEEN REPORTED PREVIOUSLY? WHICH HARMONIC SCALPEL WAS BEING USE? WAS THE USAGE OF THE HARMONIC SCALPEL ATTRIBUTABLE TO THE GALLBLADDER PERFORATION OR THE NEED FOR A BLOOD TRANSFUSION? WAS THE USAGE OF THE HARMONIC SCALPEL ATTRIBUTABLE TO ANY OF THE POST-SURGICAL COMPLICATIONS REPORTED IN THE ARTICLE? WERE ANY OF THE POST-SURGICAL COMPLICATIONS RELATED TO THE PATIENT¿S CONDITION OR EXPECTED AS PART OF THE SURGICAL PROCEDURE? WHAT MEDICAL INTERVENTION WAS USED, IF ANY, FOR THE COMPLICATIONS? CAN WE OBTAIN PATIENT SPECIFIC INFORMATION FOR THESE PATIENTS? CAN YOU PLEASE HAVE THE LOCAL SALES REP CONTACT THE SURGEONS SEEKING ANSWERS TO THESE QUESTIONS. THE SURGEON INFORMATION IS: ...

    Description of Event or Problem · 1

    DURING A REVIEW OF A JOURNAL ARTICLE BY AYMAN EL NAKEEB, M.D. ENTITLED:CLIPLESS LAPAROSCOPIC CHOLECYSTECTOMY USING THE HARMONIC SCALPEL FOR CIRRHOTIC PATIENTS: A PROSPECTIVE RANDOMIZED STUDY. SURG ENDOSC ((B)(6) 2010). GROUP A (60 PATIENTS) UNDERWENT LC BY THE TRADITIONAL METHOD (TM) WITH CLIPPING OF BOTH THE CYSTIC DUCT AND ARTERY AND DISSECTION OF THE GALLBLADDER BY DIATHERMY, AND GROUP B (60 PATIENTS) HAD LC PERFORMED USING HARMONIC SCALPEL (HS) CLOSURE AND DIVISION OF BOTH THE CYSTIC DUCT AND ARTERY WITH DISSECTION OF THE GALLBLADDER BY THE HS. GROUP B: BY DISSECTION OF CALOT¿S TRIANGLE FOLLOWED BY OCCLUSION OF BOTH THE CYSTIC DUCT AND ARTERY USING THE ACE. FOR CLOSURE OF THE CYSTIC PEDICLE AND ITS DIVISION, WE SET THE INSTRUMENT AT A POWER 2 (I.E., FOR MORE COAGULATION), AND WHEN DISSECTING THE GALLBLADDER FROM THE BED, WE SET IT AT LEVEL 5 (I.E., FOR MORE CUTTING POWER). WE CONTROLLED ANY BLEEDING FROM THE BED USING THE ACTIVE BLADE OF THE ACE. FINALLY, WE INSERTED AN ABDOMINAL DRAIN IN THE MORRISON POUCH. GALLBLADDER PREFORMATION: GROUP A HAD 11 PATIENTS; GROUP B HAD 6 PATIENTS. BLOOD TRANSFUSION: GROUP A HAD 3 PATIENTS; GROUP B HAD 2 PATIENTS. POSTOPERATIVE COMPLICATIONS RATE: PULMONARY INFECTIONS GROUP A 3; GROUP B 2 TREATED WITH ANTIBIOTICS AND CHEST MEASURES DETERIORATION OF LIVER FUNCTION GROUP A 3; GROUP B 1 TREATED WITH LIVER SUPPORT ASCETIC LEAK GROUP A 2; GROUP B 1 TREATED WITH LIVER SUPPORT WITH DIURETICS BILE LEAK GROUP A 2; GROUP B 1 TREATED WITH CONSERVATIVE MILD ENCEPHALOPATHY GROUP A 1; GROUP B 0 TREATED WITH LIVER SUPPORT WITH REPEATED COLONIC ENEMA WOUND INFECTIONS GROUP A 3; GROUP B 2 TREATED WITH ANTIBIOTICS AND DRAINAGE POSTOPERATIVE COLLECTION GROUP A 7L GROUP B 3 TREATED WITH ANTIBIOTICS AND FOLLOW-UP INCISIONAL HERNIA GROUP A 1; GROUP B 0 TREATED WITH SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350295 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE