BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22365475 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04907
    Event Type
    Injury
    Date Received
    June 30, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/30/2025. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-01420." 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: TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LAPAROSONIC COAGULATING SHEARS: A RETROSPECTIVE REPORT OF 200 CONSECUTIVE CASES AUTHORS: GREGORY M CARIO, MARK A CARLTON CITATION: AUST NZ OBSTET GYNECOLOGY. 2001; 41(3): 307. THE AUTHORS BELIEVED THAT THE TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE SHOULD BECOME THE STANDARD PROCEDURE FOR TREATMENT OF BENIGN UTERINE DISEASE, AS THE LAPAROSCOPIC OPERATION HAS FOR ECTOPIC PREGNANCY, AND THE LAPAROSCOPIC CHOLECYSTECTOMY FOR BENIGN GALLBLADDER DISEASE. THE AUTHORS PRESENTED A SERIES OF 200 CONSECUTIVE CASES OF TLH. THE OBJECTIVES OF THE STUDY WAS TO EVALUATE 200 CONSECUTIVE CASES (AGE RANGE: 30 TO 78 YEARS OLD) OF TOTAL HYSTERECTOMY USING THE LAPAROSCOPIC COAGULATING SHEARS (LCS).. DISSECTION OF THE BLADDER PERITONEUM AND MOBILIZATION OF THE BLADDER WAS ALSO PERFORMED WITH THE LCS. THE UTERINE ARTERY WAS SKELETONISED WITH THE LCS AND SUTURED BILATERALLY WITH A PDS-0 SUTURE (ETHICON) ON A CURVED NEEDLE. COLPOTOMY WAS PERFORMED WITH THE LCS AND HARMONIC SCALPEL (ETHICON) HOOK OVER THE COLPOTOMY TUBE. THE VAGINAL VAULT WAS SUTURED WITH VICRYL-0 SUTURES (ETHICON) IN THE ANGLES AND TWO ¿FIGURE OF 8¿ MONOCRYL-0 SUTURES (ETHICON) IN THE MIDLINE. VAULT SUSPENSION WAS COMPLETED WITH AT LEAST ONE HIGH MCCALL VAULT SUTURE USING DERMALON-0 (ETHICON). REPORTED COMPLICATIONS INCLUDED HEMORRHAGE (N-2) WHICH WERE TREATED INTRAOPERATIVELY USING LAPAROSCOPIC TECHNIQUES AND INFECTED VAULT HEMATOMA (N-7) WHICH REQUIRED ORAL OR INTRAVENOUS ANTIBIOTICS. THE TECHNICAL IMPROVEMENT IN THIS PROCEDURE USING THE LCS AND THE COLPOTOMISER, WITH ACCEPTABLE OPERATING TIME AND COMPLICATION RATES SHOULD MAKE THIS A ROUTINE PROCEDURE FOR HYSTERECTOMY WITH BENIGN PATHOLOGY AND SHOULD REDUCE THE NEED FOR LAVH, VH AND, MOST IMPORTANTLY, ABDOMINAL HYSTERECTOMY. THE GREAT ADVANTAGES OF MINIMALLY INVASIVE SURGERY, INCLUDING THE BENEFIT TO THE COMMUNITY, MEAN THAT TLH SHOULD BE OFFERED FREELY AS AN ALTERNATIVE TO WOMEN CONSIDERING HYSTERECTOMY AND SHOULD BE MORE WIDELY AVAILABLE IN THE COMMUNITY WITH AN UPTAKE CLOSER TO 70% THAN 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290543 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention