BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17995456 · Received October 24, 2023

    Report

    Report Number
    2210968-2023-08111
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    February 28, 2023
    Report Date
    October 24, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    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? CITATION: INTERNATIONAL JOURNAL OF UROLOGY (2023); 30, 532-538. DOI: 10.1111/IJU.15170 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: PERITONEAL CLOSURE AND THE PROCESSUS VAGINALIS TRANSECTION METHOD TO PREVENT INGUINAL HERNIA AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY. AUTHORS: TAKAHIKO SOMA,1 SHOHEI FUKUDA,1 YUSUKE MATSUYAMA,2 RIKO IKEDA,3 MASAHARU INOUE,3 YUMA WASEDA,1 HAJIME TANAKA,1 SOICHIRO YOSHIDA,1 MINATO YOKOYAMA,1 YOH MATSUOKA,3 TAKEO FUJIWARA,2 YUKIO KAGEYAMA3 AND YASUHISA FUJII1. CITATION: INTERNATIONAL JOURNAL OF UROLOGY (2023); 30, 532-538. DOI: 10.1111/IJU.15170. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE WHETHER PATIENTS WHO UNDERWENT PROCESSUS VAGINALIS TRANSECTION (PVT) OR PVT WITH PERITONEAL CLOSURE AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP) SHOWED A LOWER INCIDENCE OF INGUINAL HERNIA (IH) COMPARED WITH PATIENTS WITHOUT THESE PROCEDURES. BETWEEN JANUARY 2014 AND DECEMBER 2021, A TOTAL OF 636 JAPANESE MEN WITH ADVANCED PROSTATE CANCER WHO UNDERWENT RARP AT TWO TERTIARY HOSPITALS IN JAPAN WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE CLASSIFIED INTO THE FOLLOWING GROUPS: NO PREVENTION (WITHOUT PVT OR PERITONEAL CLOSURE; N=79; MEAN AGE OF 65 YEARS), PVT (WITH PVT BUT WITHOUT PERITONEAL CLOSURE; N=232; MEAN AGE OF 65.3 YEARS), AND PVT WITH PERITONEAL CLOSURE (WITH PVT AND PERITONEAL CLOSURE; N=325; MEAN AGE OF 68.1 YEARS). IN PERFORMING PVT, THE INTERNAL INGUINAL RING (IIR) IS PLUGGED USING A TACHOSIL TISSUE SEALING SHEET (CORZA MEDICAL GMBH DUSSELDORF GERMANY) IN SAITAMA CANCER CENTER HOSPITAL (SCC) PATIENTS OR SURGICEL ABSORBABLE HEMOSTAT (ETHICON CINCINNATI, OH, US) IN TOKYO MEDICAL AND DENTAL UNIVERSITY (TMDU) HOSPITAL PATIENTS. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE INGUINAL HERNIA (N=?). IN CONCLUSION, PVT WITH PERITONEAL CLOSURE MAY REDUCE THE RISK OF POSTOPERATIVE IH AFTER RARP. FUTURE RANDOMIZED CONTROLLED TRIALS ARE REQUIRED TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583821 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other