BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP

    MDR report key: 22375861 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05035
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    October 27, 2014
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K990362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2014. D4: BATCH # UNK. 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. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC MITROFANOFF PROCEDURE IN CHILDREN: CRITICAL ANALYSIS OF DIFFICULTIES AND BENEFITS AUTHOR: THOMAS BLANC, CECILE MULLER, MAGUELONNE PONS, POURYA PASHOOTAN, ANNABEL PAYE-JAOUEN, ALAA EL GHONEIMI. CITATION: JOURNAL OF PEDIATRIC UROLOGY (2015) 11, 28.E1-28.E8; DOI: HTTP://DX.DOI.ORG/10.1016/J.JPUROL.2014.07.013. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT THE FEASIBILITY AND POSSIBLE BENEFITS OF USING A LAPAROSCOPIC APPROACH IN CHILDREN WITH SIGNIFICANT BLADDER DYSFUNCTION ASSOCIATED WITH DIFFICULTY DOING EFFICIENT URETHRAL CATHETERIZATION. BETWEEN 2003 AND 2013, FULLY LAPAROSCOPIC MITROFANOFF (LMA) WAS ATTEMPTED IN 15 CHILDREN (MALE=12, FEMALE=3; MEAN AGE=9 YEARS). DURING THE PROCEDURE, A CAUDAL SUTURE BETWEEN THE APPENDIX AND THE BLADDER MUCOSA WAS INCLUDED THE DETRUSOR MUSCLE TO FIX THE CAUDAL PART OF THE ANASTOMOSIS AND STABILIZE THE ANASTOMOTIC LINE DURING SUTURING. AFTER COMPLETING THE ANASTOMOSIS, THE APPENDIX WAS PLACED IN THE NEWLY PREPARED DETRUSOR MUSCLE TROUGH, AND THE SEROMUSCULAR LAYER OF THE BLADDER WAS CLOSED OVER THE APPENDIX. TO AVOID COMPRESSION OF THE MESENTERY, THE SUTURES WERE DONE THROUGH THE MESENTERY UNDER LAPAROSCOPIC VISION, USING INTERRUPTED 4/0 VICRYL (ETHICON), THUS CREATING AN ANTIREFLUX MECHANISM. SOME MODFICATIONS WERE DONE BECAUSE OF THE HIGH RATE OF CONVERSION DUE TO EARLY OPENING OF THE MUCOSA (HARMONIC HOOK) OR DIFFICULT ANASTOMOSIS. HARMONIC SCALPEL (ETHICON) WAS USED IN THIS PROCEDURE. REPORTED COMPLICATIONS WITH THE USE OF HARMONIC SCALPEL INCLUDED TEARING OF BLADDER MUCOSA (N=1) WHICH WAS CONVERTED TO AN OPEN PROCEDURE; URINARY LEAKAGE FROM URETHRA (13-YEAR-OLD MALE PATIENT) AND/OR STOMA (N=5; 13-YEAR-OLD MALE, 3.5-YEAR-OLD MALE PATIENT, 7-YEAR-OLD MALE, 4-YEAR-OLD MALE, 9-YEAR-OLD MALE PATIENT). THREE PATIENTS WITH STOMAL URINARY LEAKAGE WERE SUCCESSFULLY MANAGED BY DEFLUX (DEXTRANOMER-BASED IMPLANTS) INJECTION IN THE CATHETERIZABLE CHANNEL AND REMAINED CONTINENT AFTER: 42 MONTHS IN THE 3.5-YEAR-OLD MALE PATIENT, 18 MONTHS IN THE 7-YEAR-OLD MALE PATIENT AND 2 MONTHS IN THE 4-YEAR-OLD MALE PATIENT. TWO PATIENTS (13-YEAR-OLD MALE PATIENT AND 9-YEAR-OLD MALE PATIENT) REQUIRED AN OPEN REVISION OF THE APPENDICOVESICAL ANASTOMOSIS. FURTHER, THE 13-YEAR-OLD MALE PATIENT WITH BOTH STOMAL AND URETHRAL URINARY LEAKAGE ALSO REQUIRED IMPLANTATION OF AN ARTIFICIAL URINARY SPHINCTER 1.5 YEARS AFTER THE MITROFANOFF PROCEDURE. REPORTED COMPLICATION WITH THE USE OF 4/0 VICRYL INCLUDED TEARING OF BLADDER MUCOSA (N=2; 16-YEAR-OLD FEMALE AND 7.5-YEAR-OLD MALE) WHICH THE PATIENTS WERE CONVERTED TO AN OPEN PROCEDURE. IN CONCLUSION, LAPAROSCOPIC MITROFANOFF PROCEDURE IN CHILDREN ARE UNSATISFYING IN CASES OF HIGH-PRESSURE BLADDERS IN TERMS OF INCONTINENT STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270307 HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE.