BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21334379 · Received February 7, 2025

    Report

    Report Number
    2210968-2025-01480
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    June 7, 2024
    Report Date
    February 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: ANN SURG ONCOL (2024) 31:7012¿7022 HTTPS://DOI.ORG/10.1245/S10434-024-15645-7.

    Description of Event or Problem · 0

    TITLE : ROBOTIC PANCREATODUODENECTOMY: INCREASING COMPLEXITY AND DECREASING COMPLICATIONS WITH EXPERIENCE: SINGLE-CENTER RESULTS FROM 150 CONSECUTIVE PATIENTS. THE AIM OF THIS STUDY WAS TO EVALUATE 150 RPD PROCEDURES PERFORMED BY A SINGLE SURGEON, ANALYZING TWO DIFFERENT PERIODS OF THE LEARNING CURVE. THE STUDY ENROLLED 150 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC PANCREATODUODENECTOMY BETWEEN 2018 AND 2023. THE PATIENTS WERE DIVIDED INTO TWO GROUPS. GROUP 1 COMPRISED THE FIRST 75 PATIENTS, AND GROUP 2 COMPRISED THE LAST 75 CASES. THE MEDIAN AGE OF THE PATIENTS WAS 62.4 YEARS AND DID NOT DIFFER BETWEEN THE TWO GROUPS. AN END-TO-SIDE DUCT IS USED IN MUCOSA RECONSTRUCTION. A 4-0 PROLENE SUTURE IS USED FOR THE OUTER LAYER, AND A 5-0 POLYDIOXANONE SUTURE IS USED FOR THE ANASTOMOSIS OF THE MAIN PANCREATIC DUCT IN A CONTINUOUS FASHION (FIG. 3B). NO STENT IS LEFT IN THE MAIN PANCREATIC DUCT, REGARDLESS OF ITS SIZE. IN PERFORMING HJ, 5-0 POLYDIOXANONE CONTINUOUS SUTURES ARE USED. FOR THICK BILE DUCTS, ESPECIALLY THOSE WITH LONG-TERM BILIARY PROSTHESES, 4-0 SUTURES ARE USED. THE REPORTED COMPLICATIONS INCLUDED CR-PANCREATIC FISTULA; GRADE B & C (N=9), WOUND INFECTIONS (N=1) DELAYED GASTRIC EMPTYING (N=5), BILE LEAK (N=4), AND POST PANCREATECTOMY BLEEDING (N=7). IN CONCLUSION, THE ROBOTIC PLATFORM IS USEFUL FOR PANCREATODUODENECTOMY, FACILITATES ADEQUATE LYMPHADENECTOMY, AND IS HELPFUL FOR DIGESTIVE TRACT RECONSTRUCTION AFTER RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866900 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention