BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9379239 · Received November 26, 2019

    Report

    Report Number
    3005075853-2019-23806
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    January 1, 2015
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2015 BATCH # UNK. 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. 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. DOES THE AUTHOR/ SURGEON 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

    TITLE: LAPAROSCOPIC RADICAL CHOLECYSTECTOMY FOR SUSPECTED EARLY GALL BLADDER CARCINOMA: THINKING BEYOND CONVENTION. AUTHOR: SENTHILNATHAN PALANISAMY, NIKUNJ PATEL, SANDEEP SABNIS, NALANKILLI PALANISAMY, ANAND VIJAY, PRAVEENRAJ PALANIVELU, R. PARTHASARTHI, PALANIVELU CHINNUSAMY. CITATION: SURG ENDOSC (2016) 30:2442¿2448 / DOI 10.1007/S00464-015-4495-0. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO SHARE THE INITIAL EXPERIENCE OF LAPAROSCOPIC RADICAL CHOLECYSTECTOMY (LRC) FOR SUSPECTED EARLY GALL BLADDER CARCINOMA. FROM 2008 TO 2013, A TOTAL OF 14 PATIENTS (MEAN AGE 61.14 ± 4.20 YEARS, MALE/ FEMALE RATION 1:1.33) HAD EARLY DISEASE AND UNDERWENT LRC. RESECTION PLANE WAS MARKED USING HARMONIC HOOK OR MONO-POLAR DIATHERMY AFTER CONFIRMATION OF ANATOMICAL LANDMARKS USING LAPAROSCOPIC ULTRASOUND. INITIALLY, LIVER CAPSULE WAS DIVIDED USING HARMONIC SCALPEL (ETHICON ENDO-SURGERY), WHILE DEEPER PARENCHYMAL DIVISION WAS PERFORMED USING COMBINATION OF HARMONIC SCALPEL, LIGASURE AND BIPOLAR DIATHERMY ACCORDING TO SURGEON¿S PREFERENCE. POSTOPERATIVE COMPLICATION INCLUDED BILE LEAK (N=2) WHICH WAS CONTROLLED WITH SUTURE LIGATION. FIRST PATIENT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC) AND STENTING ON 5TH POD DAY DUE TO PERSISTENT HIGH BILIOUS OUTPUT. BOTH PATIENTS RECOVERED WITHOUT NECESSITATING ANY SURGICAL INTERVENTION. LAPAROSCOPIC RADICAL CHOLECYSTECTOMY WITH LYMPHADENECTOMY CAN BE A VIABLE ALTERNATIVE FOR MANAGEMENT OF EARLY GBC IN TERMS OF TECHNICAL FEASIBILITY AND ONCOLOGICAL CLEARANCE ALONG WITH OFFERING THE CONVENTIONAL ADVANTAGES OF MINIMAL ACCESS APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171135 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1