BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9376528 · Received November 26, 2019

    Report

    Report Number
    2210968-2019-90315
    Event Type
    Injury
    Date Received
    November 26, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NUMBER HAS NOT BEEN PROVIDED. CITATION: AUST NZ OBSTET GYNECOLOGY. 2001; 41(3): 307. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE : TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LAPAROSONIC COAGULATING SHEARS: A RETROSPECTIVE REPORT OF 200 CONSECUTIVE CASES. AUTHOR : GREGORY M CARIO AND 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
    1172459 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention