BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19235710 · Received May 2, 2024

    Report

    Report Number
    2210968-2024-05077
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    September 25, 2023
    Report Date
    May 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-05078, 2210968-2024-05079. CITATIONS : INTERNATIONAL JOURNAL OF SURGERY PUBLISH: PAGES 1-33 HTTPS://DOI.ORG/10.1097/JS9.0000000000000612.

    Description of Event or Problem · 0

    TITLE : SINGLE-INCISION ROBOTIC ASSISTED SURGERY: A NON-RANDOMIZED COHORT PILOT STUDY ON A NOVEL SURGICAL PLATFORM IN COLORECTAL SURGERY. THIS NON-RANDOMIZED COHORT PILOT STUDY AIMS TO EVALUATE THE FEASIBILITY AND SAFETY OF SINGLE-INCISION ROBOTIC ASSISTED COLORECTAL SURGERY BASED ON A NOVEL ROBOTIC SURGICAL PLATFORM, THE SHURUI ENDOSCOPIC SURGICAL ROBOTIC SYSTEM (SR-ENS-600). THE 7 ENROLLED SIRAS PATIENTS HAD A MEAN (±SD) AGE OF 60.60±9.18 YEARS (RANGE FROM 44 TO 69) AND HAD A MEAN (±SD) BMI OF 24.65±2.93 KG/M2 (RANGE FROM 20.25 TO 29.20). MOST OF THE PATIENTS WERE MALE (86%) AND ALL PATIENTS WERE CLASSIFIED TO ASA GRADE I OR II. THE ABDOMINAL FASCIA WAS CLOSED WITH 1-0 PDS AND THE INCISION WAS CLOSED WITH 1 VICRYL¿ PLUS (ETHICON CO., USA) ON SUBCUTIS AND 4-0 MONOCRYL (ETHICON CO., USA) INTRADERMALLY FOR SIGMOID COLECTOMY / LOW ANTERIOR RESECTION. WHILE, IN RIGHT HEMICOLECTOMY, THE ANASTOMOSIS WAS REINFORCED BY RUNNING SUTURE AND INTERRUPTED SUTURE WITH 4-0 VICRYL¿. THE ABDOMINAL FASCIA WAS CLOSED WITH 1-0 PDS AND THE INCISION WAS CLOSED WITH 1 VICRYL¿ PLUS ON SUBCUTIS AND 4-0 MONOCRYL INTRADERMALLY. THE REPORTED COMPLICATION INCLUDED INCISIONAL HERNIA (N=1). IN CONCLUSION, SIRAS CAN BE FEASIBLY PERFORMED BY SKILLED SURGICAL TEAM VIA SR-ENS-600 PLATFORM FOR STRICTLY-SELECTED PATIENTS, WHICH PROVIDES PREFERABLE INSTRUMENT MANEUVERABILITY AND STABILITY IN CONFINED SURGICAL FIELDS AND OVERCOMES THE TECHNICAL DIFFICULTY OF MULTISITE DISSECTION THROUGH A SINGLE INCISION. LARGE-VOLUME INVESTIGATIONS AND HIGH-LEVEL EVIDENCES ARE REQUIRED TO FURTHER VALIDATE ITS SAFETY AND SUPERIORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919655 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Other