BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22383709 · Received July 2, 2025

    Report

    Report Number
    3005075853-2025-05093
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    October 29, 2020
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/30/2025. B3: PUBLICATION YEAR OF 2020. D4: BATCH#: UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA: 014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN, CAN'T REACH TO THE AUTHOR, SO NO ADDITIONAL INFORMATION CAN BE PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: THREE-DIMENSIONAL CAMERA SYSTEMS ASSISTANT THE SHEATH OF PROSTATE PRESERVATION LAPAROSCOPIC RADICAL PROSTATECTOMY: TECHNIQUE AND INITIAL EXPERIENCE. AUTHORS: LINGMIN SONG, GANG WANG, WENBO GAO, YUSHENG YANG, GUOBIN WENG. CITATION CITE: DOI: HTTPS://DOI.ORG/10.21203/RS.3.RS-97668/V1. SPP-LRP WAS PERFORMED IN 39 CONSECUTIVE MALE PATIENTS DIAGNOSED AS CLINICALLY LOCALIZED PROSTATE CANCER FROM JANUARY 2016 TO DECEMBER 2018. THESE PATIENTS WERE HIGHLY SELECTED FROM 218 DIAGNOSED AS PROSTATE CANER AND UNDERWENT RP. AFTER GENERAL ANESTHESIA, THE PATIENTS WERE PLACED IN A TRENDELENBURG POSITON WITH A F 16 FOLEY CATHETERIZATION. AFTER DISSECTING THE PUBOPROSTATIC LIGAMENT, THE DOSAL VENOUS COMPLEX (DVC) WAS LIGATED BY 20CM 2-0 SPIRAL PGA-PCL (ETHICON INC., SOMERVILLE, NJ, USA) WITHOUT EXCISION. ALONG THE SURFACE OF THE PROSTATE CAPSULE EXPOSED, DISSECTIONS WERE PERFORMED BETWEEN THE BLADDER NECK AND THE PROSTATE TO EXPOSE THE ANTERIOR AND BILATERAL CONNECTION PART OF THE BLADDER NECK AND THE URETHRA. THEN THE ANTERIOR 1/2 OF THE CONNECTION WAS DISSECTED BY ULTRASONIC SCALPEL (ETHICON), FOLLOWED BY PULLING OUT THE CATHETER. HEMOSTASIS WAS DONE ONLY BY SUTURE WITH 3-0 COAED VICRYL PLUS (ETHICON INC SOMERVILLE, NJ, USA) AND THE PROSTATIC FASICA WAS KEPT INTACT BILATERALLY TO AVOID ANY INJURY ON NVB. A RUNNING ANASTOMOSIS BETWEEN THE VESICAL NECK AND THE URETHRA USING A 25-CM,2-0 MONOCRYL (ETHICON INC., SOMERVILLE, NJ, USA) WAS PERFORMED. REPORTED COMPLICATIONS INCLUDED POSITIVE RESECTION MARGINS FOR TUMOR (N=3), PELVIC LYMPH NODE METASTASIS (N=1). IN CONCLUSION SPP-LRP IS A PRACTICAL AND WORTH-PROMOTING TECHNIQUE FOR RP. THE INITIAL RESULTS ARE PREFERABLE AND PROMISING IN TECHNICAL, ONCOLOGICAL AND FUNCTIONAL ASPECTS. AND THE EARLY CONTINENCE RECOVERY MAKE IT POSSIBLE FOR PATIENTS WITH R1 TO RECEIVE POSTOPERATIVE RADIOTHERAPY AT EARLY STAGE. A CONTROL PERSPECTIVE CLINICAL TRIAL AND A LONG-TERM FOLLOW-UP ARE MANDATORY TO CONFIRM THE RESULTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153203 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention