BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 14349605 · Received May 10, 2022

    Report

    Report Number
    2210968-2022-03562
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    January 5, 2021
    Report Date
    May 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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? 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). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA / EVENTS WERE SUBMITTED VIA 2210968-2022-03561 AND 2210968-2022-03563. CITATION: SURGICAL ENDOSCOPY (2021) 35:6873¿6881, HTTPS://DOI.ORG/10.1007/S00464-020-08194-Z.

    Description of Event or Problem · 0

    TITLE: ROBOTIC COMPLETE MESOCOLIC EXCISION (CME) IS A SAFE AND FEASIBLE OPTION FOR RIGHT COLONIC CANCERS: SHORT AND MIDTERM RESULTS FROM A SINGLE-CENTRE EXPERIENCE. THE AIM OF THIS STUDY IS TO DESCRIBE THE RESULTS OF A STANDARDISED TECHNIQUE FOR COMPLETE MESOCOLIC EXCISION SURGERY FOR COLON CANCER WITH THE USE OF DAVINCI ROBOTIC PLATFORM. BETWEEN JANUARY 2015 AND SEPTEMBER 2019, 77 PATIENTS UNDERGOING STANDARDISED ROBOTIC COMPLETE MESOCOLIC EXCISION TECHNIQUE WITH SUPERIOR MESENTERIC VEIN FIRST APPROACH WERE INCLUDED IN THE STUDY. THERE WERE 34 MALES AND 43 FEMALES WITH A MEDIAN AGE OF 69 (34¿89) YEARS. DURING THE PROCEDURE, COMMON ENTEROTOMY (STAPLER ENDS) IS CLOSED WITH TWO-LAYER VICRYL 3/0 STITCH (ETHICON). THE SPECIMEN IS EXTRACTED THROUGH SUPRAPUBIC PFANNENSTIEL INCISION. A LAYERED CLOSURE IS PERFORMED WITH PDS (ETHICON) AND MONOCRYL (ETHICON) SUTURES. COMPLICATIONS INCLUDE SMALL BOWEL INJURY (N=1), SMALL BOWEL OBSTRUCTION (N=1), WOUND INFECTION (N=3), ILEUS (N=3), AND ABDOMINAL PAIN (N=1). IN CONCLUSION, ROBOTIC COMPLETE MESOCOLIC EXCISION IS FEASIBLE, EFFECTIVE AND SAFE. GOOD ONCOLOGICAL RESULTS AND IMPROVED SURVIVAL ARE SEEN IN THIS COHORT OF PATIENTS WITH A STANDARDISED APPROACH TO ROBOTIC COMPLETE MESOCOLIC EXCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036671 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention