BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS UNKNOWN

    MDR report key: 18876950 · Received March 11, 2024

    Report

    Report Number
    2210968-2024-02825
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL STRENGTH ¿ = 2360 G/M 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: THE AMERICAN SURGEON¿ 2023; 89(4):1173¿1174. HTTPS://DOI.ORG/10.1177/0003134820982861.

    Description of Event or Problem · 0

    TITLE: CLOSURE OF CHOLEDOCHOTOMY WITH A BARBED ABSORBABLE SUTURE AFTER LAPAROSCOPIC COMMON BILE DUCT EXPLORATION THE AIM OF THIS STUDY IS TO DESCRIBE THE SHORT- AND MEDIUM-TERM RESULTS OF PRIMARY CLOSURE WITH BARBED SUTURE (B)(6) 2019, A TOTAL OF 221 PATIENTS WHO UNDERWENT LAPAROSCOPIC CHOLEDOCHOTOMY PLUS PRIMARY CLOSURE USING BARBED SUTURES WERE INCLUDED. THE MEAN AGE WAS 54.4 YEARS, AND 131 PATIENTS (59.3%) WERE WOMEN. THE AVERAGE CBD DIAMETER WAS 13.9 ± 3.8 MM; 2.1 ± 1.3 STONES WERE REMOVED FROM THE CBD. THE ADHESION AROUND THE GALLBLADDER WAS SEPARATED BY A HARMONIC SCALPEL (ETHICON, USA) TO EXPOSE THE CALOT¿S TRIANGLE. THE CBD INCISION WAS PRIMARILY CLOSED WITH 4-0 STRATAFIX SPIRAL POLYDIOXANONE (ETHICON) CONTINUOUS SUTURE. THE FOLLOW-UP PERIOD LASTED UP TO JULY 31, 2020, AND THE MEAN FOLLOW-UP WAS 28.2 MONTHS. REPORTED COMPLICATIONS INCLUDE BILE LEAKAGE (N=9), INTRA-ABDOMINAL INFECTION (N=2), INTRA-ABDOMINAL BLEEDING (N=1), GASTRODUODENAL SEROSAL INJURY (N=1), AND INCISIONAL INFECTION (N=1). IN CONCLUSION, PRIMARY CLOSURE WITH BARBED SUTURE FOLLOWING LCBDE IS A SAFE AND EFFECTIVE TREATMENT FOR THE MANAGEMENT OF CBD STONES IN SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468892 STRATAFIX SPIRAL PDS PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other