BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15610100 · Received October 14, 2022

    Report

    Report Number
    2210968-2022-08450
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    July 19, 2021
    Report Date
    October 14, 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
    IN
    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. 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). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-08449. CITATION: JOURNAL OF ROBOTIC SURGERY (2022) 16:587¿596 HTTPS://DOI.ORG/10.1007/S11701-021-01282-9

    Description of Event or Problem · 0

    TITLE: COLORECTAL CANCER SURGERY: BY CAMBRIDGE MEDICAL ROBOTICS VERSIUS SURGICAL ROBOT SYSTEM¿A SINGLE-INSTITUTION STUDY. OUR EXPERIENCE. THE AIM OF THE STUDY IS A PROSPECTIVE ANALYSIS AND EVALUATION OF SHORT-TERM RESULTS OF CONSECUTIVE PATIENTS TO STUDY THE TECHNICAL FEASIBILITY AND ONCOLOGICAL OUTCOME OF ROBOT-ASSISTED LOW ANTERIOR RESECTION (LAR) AND ULTRALOW ANTERIOR RESECTION (ULAR), USING THE CMR VERSIUS SURGICAL ROBOT SYSTEM. THIS STUDY WAS CONDUCTED AT SINGLE MINIMAL ACCESS SURGERY INSTITUTE. 31 PATIENTS WITH COLORECTAL ADENOCARCINOMA UNDERWENT ROBOT-ASSISTED LAR AND ULAR BETWEEN AUGUST 2019 AND MARCH 2020. 23 WERE MEN AND 8 WOMEN, WITH MEAN AGE OF 55.6 YEARS. 2/0 VICRYL SUTURE (ETHICON), ECHELON 60 BOWEL STAPLER (JOHNSON AND JOHNSON, USA) , CCD 33 MM CIRCULAR STAPLER ANVIL (JOHNSON AND JOHNSON, USA), PROLENE 2¿0 (ETHICON), REPORTED COMPLICATIONS INCLUDED ILEUS (N=2), SURGICAL SITE INFECTION (N=3), ANASTOMOTIC DEHISCENCE (N=1). IN CONCLUSION THE CMR VERSIUS ROBOT HAS ALL THE QUALITIES IN TERMS OF DEXTERITY, VISION AND INTUITIVE MOVEMENTS.THE MOST IMPORTANT ADVANTAGE IS TO TRANSLATE THIS TECHNICAL ABILITY INTO ONCOLOGICAL SAFETY. THE QUALITY OF TME ACHIEVED IS COMPARABLE TO THAT OF LAPAROSCOPY. THE SAME ROBOTIC PORTS CAN BE USED FOR THE LAPAROSCOPIC INSTRUMENTS. THE MOBILE ARMS OF THE ROBOTIC SYSTEM ARE AN ADDED ADVANTAGE OF THIS SYSTEM.THE SHORT-TERM RESULTS ARE PROMISING IN TERMS OF MORBIDITY AND TIME TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666334 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention