BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9454115 · Received December 11, 2019

    Report

    Report Number
    3005075853-2019-24188
    Event Type
    Injury
    Date Received
    December 11, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/11/2019. DATE OF EVENT: 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.

    Description of Event or Problem · 1

    TITLE: ROBOTIC-ASSISTED RESECTIONS OF POSTERIOR LIVER SEGMENTS. AUTHOR/S: EFANOV M.; ALIKHANOV R.; CVIRCUN V.; KAZAKOV I.; MELEKHINA O.; VANKOVICH A.; KIM P.; KHATKOV I. CITATION: 5TH BIENNIAL CONGRESS OF THE ASIAN-PACIFIC HEPATO-PANCREATO-BILIARY ASSOCIATION. SINGAPORE. 17 (SUPPL. 2) (PP 275-276), 2015. THIS STUDY DISCUSSED ABOUT THE TEN ROBOTIC-ASSISTED RESECTIONS OF POSTERIOR LIVER SEGMENTS. INDICATIONS INCLUDED: ALVEOLAR ECHINOCOCCUS OF S 6,7 (N=1), CYSTADENOMA OF S 6,7 (N=1), COLORECTAL METASTASES OF S 3,4, 5,8 (N=1), S 6,7 (N=2), HYDATID ECHINOCOCCUS OF S 2-7 (N=2), GEMANGIOMAS OF S 6,7 (N=1), OF S 2,3,5,8 (N=1) AND INTRAHEPATIC CHOLELITHIASIS (N=1). HARMONIC SCISSORS (ETHICON) WAS USED FOR LIVER PARENCHYMA TRANSECTION. REPORTED COMPLICATIONS INCLUDED MEAN BLOOD LOSS DURING RESECTION OF S 6,7 CONSISTED 720 ± 350 ML (N=2); BILIARY FISTULA (N=1). IN CONCLUSION, ROBOTIC-ASSISTED LIVER RESECTIONS ARE LONGER IN DURATION IN COMPARISON WITH OPEN LIVER RESECTIONS. IMPROVEMENT OF SHORT-TERM RESULTS IS EXPECTED IN CONFORMITY WITH LEARNING CURVE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249799 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other