BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 21585212 · Received March 12, 2025

    Report

    Report Number
    3005075853-2025-01936
    Event Type
    Death
    Date Received
    March 12, 2025
    Date of Event
    April 19, 2024
    Report Date
    March 12, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/12/2025. B3: PUBLICATION YEAR OF 2024. D4: 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 AND/OR DEATH MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN IS THE AUTHOR/SURGEON INTERESTED IN SPEAKING WITH AN ETHICON MEDICAL PROFESSIONAL? 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: A COMPARATIVE STUDY BETWEEN LAPAROSCOPIC SPLENECTOMY VERSUS OPEN SPLENECTOMY. AUTHOR:1JAGDISH PRASAD, 2PARVINDER SINGH SANDHU. CITATION: ONLINE ISSN: 2250-3137. PRINT ISSN: 2977-0122. THE STUDY WAS A RANDOMIZED COMPARATIVE STUDY CONDUCTED IN THE DEPARTMENT OF GENERAL SURGERY OF SAWAI MAN SINGH HOSPITAL, JAIPUR. INITIALLY, SPLENECTOMY WAS DONE BY OPEN TECHNIQUE, INDICATIONS BEING MAINLY HAEMATOLOGICAL DISORDERS. CHRONIC ITP. WITH GROWING EXPERIENCE AND ADVANCEMENT IN TECHNOLOGY THE LAPAROSCOPIC APPROACH EXTENDED TO CYSTS,TUMOURS, STORAGE DISEASES AND EVEN TRAUMA IT WAS ALSO USED FOR HAEMATOLOGICAL DISORDERS MAINLY CHRONIC ITP. WITH GROWING EXPERIENCE AND ADVANCEMENT IN TECHNOLOGY THE LAPAROSCOPIC APPROACH EXTENDED TO CYSTS, TUMORS, STORAGE DISEASES AND EVEN TRAUMA. BETWEEN JUNE 2011 TO JUNE 2012. TOTAL 25 PATIENTS WERE INCLUDED IN STUDY PROSPECTIVELY INTO TWO GROUPS, GROUP A & GROUP B. GROUP A(N= 12 AND N=13) CASES IN GROUP B RESPECTIVELY. THE PATIENTS IN GROUP A UNDERWENT LAPAROSCOPIC SPLENECTOMY. WHILE GROUP B UNDERWENT OPEN SPLENECTOMY. THE MEAN AGE IN GROUP A WAS 35.41 YEARS WHILE IN GROUP B WAS 29.53 YEARS. SPLENIC SPAN OF 11-20 CM WAS FOUND IN 33% PATIENTS IN GROUP A AND 46% OF PATIENTS IN GROUP B .MINIMUM PREOPERATIVE PLATELET COUNT IN GROUP A WAS 7000/L IN A CASE OF I.T.P. AND THAT IN GROUP B WAS 30000/L. ACCESSORY SPLEEN WAS DETECTED IN 1 OF THE PATIENT (8%) IN LAPAROSCOPIC GROUP WHEREAS NONE OF THE PATIENT WAS FOUND TO BE HAVING ACCESSORY SPLEEN IN OPEN GROUP. GROUP A DEVELOPED STEROID TOXICITY IN THE FORM OF HYPERTENSION, DIABETES AND PAN GASTRITIS .THE OPERATIVE TIME IN GROUP A WAS IN THE RANGE OF 90-360 MINUTES WITH MEAN OPERATING TIME OF 18. MEAN INTRA OPERATIVE BLOOD LOSS IN GROUP A WAS 60 ML ±38 ML AND FOUND TO BE LESS THAN GROUP B MEAN DRAIN OUTPUT WAS 134ML± 145ML IN GROUP A WITH RANGE OF 50-550ML IN GROUP-A MEAN FOLLOW UP PERIOD WAS 9 MONTHS WITH A RANGE OF 4-18 MONTHS. IN GROUP-B MEAN FOLLOW UP PERIOD WAS 7 MONTHS WITH A RANGE OF 1-18 MONTHS. COMPLICATION DURING THE PERIOD OF FOLLOW UP WAS FOUND IN 17% OF PATIENTS IN GROUP-A AND 15% IN GROUP B. ENDOSTAPLER (ENDOLINEAR CUTTER ATS FLEX 45MM; ECHELON 60M.) WAS USED IN GROUP-A HILAR CONTROL WAS ACHIEVED. ETHILON 3-0 SUTURES WAS USED WHEN THE SKIN SUTURES WERE APPLIED. HARMONIC SCALPEL USED WHEN THE PERITONEUM OVERLYING THE SPLENIC VESSELS WAS DIVIDED REPORTED COMPLICATIONS: HARMONIC DEVICE (ETHICON ENDO-SURGERY). DEATH ON SECOND POST-OPERATIVE DAY DUE TO INTRA ABDOMINAL HEMORRHAGE LEADING TO SHOCK WHICH WAS SEEN DURING RE-EXPLORATION AS DIFFUSE PERITONEAL BLEEDING (N=1). IN CONCLUSION, LAPAROSCOPIC SPLENECTOMY IS SAFE AND EFFICACIOUS FOR MILD TO MODERATE SIZE SPLEENS. THE OPERATIVE TIME FOR LAPAROSCOPIC SPLENECTOMY IS LONGER THAN OPEN SPLENECTOMY BUT AFTER ACHIEVING LEARNING CURVE IT CAN BE SHORTENED SIGNIFICANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434226 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death