BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 17701952 · Received September 7, 2023

    Report

    Report Number
    2210968-2023-06474
    Event Type
    Death
    Date Received
    September 7, 2023
    Date of Event
    January 1, 2022
    Report Date
    October 5, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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/DEATH 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? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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 2210968-2023-06474 AND 2210968-2023-06475. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES, VOLUME 32, NUMBER 6, 2022 DOI: 10.1089/LAP.2021.0714.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF HAND-SEWN WITH STAPLED ANASTOMOSIS IN NEONATAL INTESTINAL ATRESIA SURGERY: A RANDOMIZED CONTROLLED STUDY. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE SAFETY AND EFFICACY OF HAND-SEWN VERSUS STAPLED ANASTOMOSIS THERAPY IN INTESTINAL ATRESIA NEONATAL PATIENTS. THIS WAS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL IN WHICH 90 NEONATES WITH INTESTINAL ATRESIA WERE RANDOMLY DIVIDED INTO THE HAND-SEWN GROUP AND THE STAPLED GROUP. ALL PATIENTS WERE ASSIGNED TO UNDERGO INTESTINAL ANASTOMOSIS BY HAND-SEWN OR STAPLER. THERE WERE 45 PATIENTS FOR THE HAND SEWN GROUP, 28 MALES AND 17 FEMALES WITH THE MEAN AGE OF 3-4 DAYS OLD. THEY USED 5/0 VICRYL (ETHICON) IN THE HAND SEWN GROUP AND DURING SINGLE LAYER INTERRUPTED INTESTINAL ANASTOMOSES. THE REPORTED COMPLICATIONS INCLUDED DEATH (N=2) DUE TO PERITONITIS AND GUT FAILURE. ANASTOMOTIC LEAKAGE (N=3) TREATMENT: NOT MENTIONED, ANASTOMOTIC STRICTURE (N=7) TREATMENT: NOT MENTIONED. IN CONCLUSION, OUR RESULTS SHOW THAT STAPLED ANASTOMOSIS IS SAFE AND EFFECTIVE FOR INTESTINAL ATRESIA, AS IT CAN SHORTEN OPERATIVE TIME, WITH DECREASED INTRAOPERATIVE DURATION, EARLY RETURN OF PERISTALSIS, EARLY START OF FEEDS, AND SHORTER DURATION OF HOSPITAL STAY. WE ALSO CONCLUDE THAT THE WEIGHT OF NEONATES IS NOT A LIMITATION FOR USING ENDOSCOPIC LINEAR CUTTING STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101488 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death