BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9980825 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03250
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    March 25, 2020
    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 · 1

    (B)(4). 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. 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 ETHICON PRODUCTS (PDS SUTURE, VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADDVANCED SURGICAL TECHNIQUES (2019); 29 (9): 1197-1200. DOI: 10.1089/LAP.2019.0326. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: APPLICATION OF AN EXTRACORPOREAL-ASSISTED INTRACORPOREAL SLIDING KNOT-TYING TECHNIQUE IN MINIMALLY INVASIVE SURGERY IN CHILDREN" AUTHORS: CHENGHAO CHEN, MD, PHD, QI ZENG, MD, NA ZHANG, MD, JIE YU, MD, DONG YAN, MD, CHANGQI XU, MD, DINGYI LIU, MD, QIAN ZHANG, MD, AND XU ZHANG, MD. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES (2019); 29 (9): 1197-1200. DOI: 10.1089/LAP.2019.0326. A RETROSPECTIVE STUDY WAS CARRIED OUT TO DETERMINE THE FEASIBILITY AND SAFETY OF AN EXTRACORPOREAL ASSISTED INTRACORPOREAL SLIDING KNOT-TYING TECHNIQUE IN MINIMALLY INVASIVE SURGERY IN CHILDREN. FROM JUNE 2009 TO DECEMBER 2017, 333 CASES (MEAN AGE: 1.7 YEARS; AGE RANGE: 2 MONTHS TO 9 YEARS) OF THORACOSCOPIC/LAPAROSCOPIC SURGERY WERE PERFORMED USING EXTRACORPOREAL-ASSISTED INTRACORPOREAL SLIDING KNOT-TYING TECHNIQUE. A 4-0 NONABSORBABLE POLYESTER SUTURE WAS USED FOR FUNDOPLICATION, 4-0 OR 5-0 ABSORBABLE POLYDIOXANONE (PDS) OR VICRYL (ETHICON) SUTURE WAS USED FOR END-TO-END ESOPHAGEAL ANASTOMOSIS. REPORTED COMPLICATION INCLUDED SMALL CONTAINED ANASTOMOTIC LEAKS (N-2) IN WHICH AFTER CONSERVATIVE TREATMENT FOR 2¿3 WEEKS, BOTH RECOVERED AND WERE DISCHARGED FROM HOSPITAL. THE EXTRACORPOREAL ASSISTED INTRACORPOREAL SLIDING KNOT-TYING TECHNIQUE DESCRIBED IN THIS STUDY IS SAFE AND FEASIBLE. IT IS SUITABLE FOR KNOTTING IN VARIOUS MINIMALLY INVASIVE ENDOSCOPIC SURGERIES, ESPECIALLY FOR SUTURING TISSUES WITH TENSION, SUCH AS THORACOSCOPIC DIAPHRAGMATIC HERNIA REPAIR, LAPAROSCOPIC ESOPHAGEAL HIATAL HERNIA REPAIR, AND FUNDOPLICATION. ALL TYPES OF SUTURES CAN BE USED IN THIS KNOTTING TECHNIQUE. THIS KNOTTING TECHNIQUE HAS A SHORT LEARNING CURVE AND CAN BE QUICKLY MASTERED BY SURGEONS WHO ARE EXPERIENCED IN ENDOSCOPIC SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444734 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention