BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19003837 · Received March 29, 2024

    Report

    Report Number
    2210968-2024-03665
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 29, 2022
    Report Date
    March 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. CITATION: ANN COLOPROCTOL 2022 MAR 29. HTTPS://DOI.ORG/10.3393/AC.2021.00983.0140.

    Description of Event or Problem · 0

    TITLE: INTRACORPOREAL VERSUS EXTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC RIGHT HEMICOLECTOMY: A RETROSPECTIVE COHORT STUDY OF ANASTOMOTIC COMPLICATIONS. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO EVALUATE THE INFLUENCE OF THE TECHNIQUE USED FOR ANASTOMOSIS ON INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES OF PATIENTS WITH LAPAROSCOPIC SURGERY PERFORMED IN A TERTIARY COLORECTAL SURGERY CENTER WITH AN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROGRAM. BETWEEN JANUARY 2015 TO DECEMBER 2019, A TOTAL OF 285 PATIENTS WHO UNDEREWNT ELECTIVE LAPAROSCOPIC RIGHT HEMICOLECTOMY (LRH) WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO THE TYPE OF ANASTOMOSIS PERFORMED: INTRACORPOREAL ANASTOMOSIS (IA) WAS PERFORMED IN 64 PATIENTS (35 MALE AND 29 FEMLE; MEAN AGE WAS 71±10 YEARS) WHILE EXTRACORPOREAL ANASTOMOSIS (EA) WAS PERFORMED IN 221 PATIENTS (123 MALE AND 98 FEMALE; MEAN AGE WAS 71±10 YEARS). FOR PATIENTS IN IA GROUP, STAPLE LINE WAS REINFORCED WITH SEROMUSCULAR VICRYL 3-0 SUTURE (ETHICON, RARITAN, NJ, USA). REPORTED COMPLICATIONS INCLUDE INTRAOPERATIVE COMPLICATIONS (N=3), ANASTOMOTIC COMPLICATION SUCH AS BLEEDING (N=2), AND SURGICAL SITE INFECTION (N=3). IN CONCLUSION, FOR LRH, BOTH IA AND EA ARE SAFE, WITH A LOW INCIDENCE OF COMPLICATIONS WHEN PERFORMED BY EXPERIENCED SURGEONS. IA MAY BE ASSOCIATED WITH A LOWER INCIDENCE OF INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593839 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention