BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15752005 · Received November 8, 2022

    Report

    Report Number
    2210968-2022-09226
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    March 11, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-09227. CITATION: IN VIVO 36: 1432-1437 (2022), HTTPS://DOI.ORG/10.21873/INVIVO.12848.

    Description of Event or Problem · 0

    TITLE: UTILITY OF ROBOT-ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR OF INGUINAL HERNIA FOLLOWING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE FEASIBILITY OF ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR (R-TAPP) REPAIR OF POSTPROSTATECTOMY INGUINAL HERNIA (PIH) IN PATIENTS FOLLOWING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP) COMPARED TO THOSE WHO DID NOT UNDERGO ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP). BETWEEN SEPTEMBER 2016 AND OCTOBER 2020 , SEVENTY FOUR PATIENTS (MALE:FEMALE=71:3) WHO UNDERWENT ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR (R-TAPP) WERE REGISTERED AT AGEO CENTRAL GENERAL HOSPITAL WERE REVIEWED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE PRESENCE OF POSTPROSTATECTOMY INGUINAL HERNIA (PIH) FOLLOWING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP). THUS, FINAL ANALYSIS WAS PERFORMED ON 16 PATIENTS ,WITH MEDIAN 68.1 (61-80 YEARS ), WITH POSTPROSTATECTOMY INGUINAL HERNIA (PIH) AND 54 PATIENTS, WITH MEDIAN AGE OF 68.1 (61-80 YEARS ) , WITHOUT. TWENTY-NINE PATIENTS UNDERWENT ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR (R-TAPP) ON THE RIGHT, 22 ON THE LEFT, AND 19 BILATERALLY. DURING OPERATION , THE PERITONEUM WAS CLOSED WITH CONTINUOUS SUTURES USING MONOFILAMENT THREAD (3-0 PROLENE®; ETHICON INC. SUNRISE, FL, USA) AND THE PERITONEAL CLOSURE WAS ACCOMPLISHED WITH 4-0 POLYDIOXANONE MONOFILAMENT SUTURE (ETHICON INC. SUNRISE, FL, USA) WITH SEQUENTIAL RUNNING SUTURES USING ONE OR TWO THREADS. REPORTED COMPLICATIONS INCLUDED: (N=1) PATIENT WITH A HAEMATOMA (CLAVIEN-DINDO CLASSIFICATION I) IN THE NON-POSTPROSTATECTOMY INGUINAL HERNIA (PIH) GROUP. IT WAS CONCLUDED , THAT ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR (R-TAPP) IS A FEASIBLE AND SAFE APPROACH FOR INGUINAL HERNIA REPAIR, EVEN IN PATIENTS WHO UNDERGO ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP) FOR PROSTATE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010234 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization