BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9519537 · Received December 26, 2019

    Report

    Report Number
    3005075853-2019-24756
    Event Type
    Injury
    Date Received
    December 26, 2019
    Report Date
    November 29, 2019
    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). DATE SENT: 12/26/2019. DATE OF EVENT: PUBLICATION YEAR OF 2012. 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 PANCREATECTOMY FOR BENIGN/LOW MALIGNANT LESIONS. AUTHOR : MISAWA T.; FURUKAWA K.; KITAMURA H.; SUZUKI F.; ITO R.; GOCHO T.; SHIBA H.; FUTAGAWA Y.; WAKIYAMA S.; ISHIDA Y.; YANAGA K. CITATION: SURG ENDOSC (2012) 26(SUPPL 1): 249. / HTTPS://DOI.ORG/10.1007/S00464-012-2203-X. THE PURPOSE OF THIS STUDY WAS TO PRESENT THE TECHNICAL REFINEMENTS OF OUR LAPAROSCOPIC PANCREATECTOMY INCLUDING DISTAL PANCREATECTOMY AND ENUCLEATION BY PURE LAPAROSCOPIC (PL), HAND-ASSISTED LAPAROSCOPIC (HL), AND SINGLE-INCISION LAPAROSCOPIC (SL) SETTINGS. FROM MAY 2005, A TOTAL OF 33 LAPAROSCOPIC PANCREATECTOMIES WERE PERFORMED. IN ENUCLEATION FOR NET, HARMONIC SCALPEL (ETHICON) WAS EMPLOYED FOR PANCREATIC RESECTION. POSTOPERATIVE COMPLICATION INCLUDED CLINICALLY SIGNIFICANT (GRADE B) PANCREATIC FISTULA (N=1). THOUGH LAPAROSCOPIC DISTAL PANCREATECTOMY IS A SAFE AND OPTIMAL PROCEDURE FOR BENIGN/LOW-MALIGNANT LESION IN THE PANCREAS, SPECIAL ATTENTION SHOULD BE PAID TO THEIR MALIGNANT POTENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312944 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other