BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 17986037 · Received October 23, 2023

    Report

    Report Number
    2210968-2023-08098
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? EVENT RELATED TO 2210968-2023-08099. CITATION: CASE REPORTS IN OBSTETRICS AND GYNECOLOGY/VOLUME 2023, ARTICLE ID 5071080, 10 PAGES/HTTPS://DOI.ORG/10.1155/2023/5071080. 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 A JOURNAL ARTICLE: TITLE: URETER INJURY IN TOTAL LAPAROSCOPIC HYSTERECTOMY AUTHOR: HIROHARU KOBAYASHI , AIMI ODA, YOSHIHIKO MATSUZAKI, YUKI KONDO, YURI HAMADA, MASARU NAGASHIMA, MISA KOBAYASHI, YOSHIHIRO TAKAKI, AND HIROSHI ADACHI CITATION: CASE REPORTS IN OBSTETRICS AND GYNECOLOGY/VOLUME 2023, ARTICLE ID 5071080, 10 PAGES/HTTPS://DOI.ORG/10.1155/2023/5071080. THE AIM OF THE STUDY WAS TO IDENTIFY SURGICAL MANIPULATIONS THAT CAUSED URETER INJURY DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) AND EVALUATE THE SURGICAL MANIPULATIONS TO IDENTIFY WAYS TO PREVENT SUCH INJURY. SINGLE-CENTER, CROSS-SECTIONAL STUDY INCLUDED 1135 CASES OF TLH PERFORMED FOR BENIGN DISEASES FROM JANUARY 2009 TO DECEMBER 2021. SEVEN CASES THAT NEEDED URETERAL STENT PLACEMENT INTRA- OR POSTOPERATIVELY FOR URETER INJURY. REPORTED COMPLICATIONS ARE ABSCESS, INFECTION, ADHESION, URETER INJURY AND BLEEDING. IN CONCLUSION, TO PREVENT URETER INJURY DURING TLH, THE URETER SHOULD BE ISOLATED IN CASE OF SEVERE ADHESION. MOREOVER, THE FOLLOWING COULD BE CONSIDERED: (1) EXPAND OKABAYASHI¿S PARARECTAL SPACE LATERAL TO THE UTEROSACRAL LIGAMENT, (2) PERFORM DISSECTION SHARPLY USING A MONOPOLAR OR SCISSORS FORCEPS WHEN RELEASING ADHESION, (3) CLARIFY THE ANATOMY AROUND THE URETER FOR CASES NEEDING HEMOSTASIS, (4) REPEATEDLY CONFIRM THE URETER WITH ITS PERISTALSIS EVEN AFTER ITS ISOLATION, (5) FOR SEVERE ADHESION CASES, REDUCE INFECTION RISK BY DRAIN PLACEMENT AND ADMINISTERING ANTIBIOTICS, AND (6) USE A DELINEATOR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227745 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other