BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15674498 · Received October 26, 2022

    Report

    Report Number
    2210968-2022-08792
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    March 1, 2021
    Report Date
    October 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL ENDOSCOPY (2022) 36:1053¿1063. HTTPS://DOI.ORG/10.1007/S00464-021-08371-8.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC COMMON BILE DUCT EXPLORATION WITH PRIMARY CLOSURE IS BENEFICIAL FOR PATIENTS WITH PREVIOUS UPPER ABDOMINAL SURGERY. THIS STUDY AIMS TO EVALUATE THE FEASIBILITY AND BENEFITS OF LCBDE-PC FOR PATIENTS WITH PUAS. FROM JUNE 2011 TO SEPTEMBER 2019, 1167 PATIENTS WHO UNDERWENT LAPAROSCOPIC PROCEDURES FOR CHOLEDOCHOLITHIASIS WERE REVIEWED RETROSPECTIVELY. PERIOPERATIVE OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT PUAS IN UN-MATCHED AND MATCHED COHORTS. THE INCISION OF THE CBD WAS CLOSED USING ABSORBABLE 4¿0 PDS II SUTURES (ETHICON INC., SOMERVILLE, N.J., USA) WITHOUT STENT IMPLANTATION. REPORTED COMPLICATIONS INCLUDED BILE LEAKAGE (N=9), INTRA-ABDOMINAL FLUID COLLECTION (N=2) IN CONCLUSION LCBDE-PC IS FEASIBLE AND BENEFICIAL FOR PATIENTS WITH PUAS. HOWEVER, PATIENTS WITH PUAS WITH A HIGH POSSIBILITY OF LCBDE-PC FAILURE FROM THE NOMOGRAM AND A LONGER OPERATIVE TIME FROM THE LINEAR REGRESSION MODEL SHOULD BE CAUTIOUS WHEN UNDERGOING LCBDE-PC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509374 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention