BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12712928 · Received October 28, 2021

    Report

    Report Number
    2210968-2021-10487
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    June 1, 2019
    Report Date
    October 28, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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? 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: SURG ENDOSC (2019), VOLUME 33, PAGE S503. .

    Description of Event or Problem · 0

    TITLE: BARBED SINGLE LAYER VERSUS HYBRID DOUBLE LAYER CLOSURE OF THE ENTEROTOMY IN LAPAROSCOPIC RIGHT COLECTOMY WITH INTRACORPOREAL MECHANICAL ANASTOMOSIS AUTHORS: A. COSSU, U. ELMORE, A. VIGNALI, R. ROSATI CITATION: SURG ENDOSC (2019), VOLUME 33, PAGE S503 THIS STUDY TO ASSESS THE SAFETY AND EFFICACY OF SINGLE LAYER OF BARBED VS DOUBLE LAYER ¿HYBRID¿ (INTERRUPTED AND RUNNING) SUTURE FOR THE CLOSURE OF ANASTOMOTIC STAPLER ACCESS ENTEROTOMY AFTER LAPAROSCOPIC RIGHT COLECTOMY WITH INTRACORPOREAL ANASTOMOSIS. FROM APRIL 2014 TO NOVEMBER 2018, 72 PATIENTS WHO UNDERWENT LAPAROSCOPIC RIGHT COLECTOMY WITH INTRACORPOREAL ANASTOMOSIS WITH THE ENTEROTOMY CLOSED WITH A SINGLE LAYER RUNNING COMPETITOR¿S SUTURE WERE MATCHED WITH 72 PATIENTS WITH ENTEROTOMY CLOSED WITH A ¿HYBRID¿ DOUBLE LAYER TECHNIQUE (FIRST LAYER INTERRUPTED STITCHES USING A COMPETITOR¿S SUTURE), SECOND LAYER USING A RUNNING SUTURE IN PDS 3-0 (ETHICON). ALL PATIENTS IN BOTH GROUPS WERE PERIOPERATIVELY MANAGED USING AN ERAS PATHWAY. COMPLICATIONS INCLUDE ANASTOMOTIC LEAK (N=5) WITH INTRAOPERATIVE FINDINGS OF A LEAK AT THE ENTEROTOMY CLOSURE (N=2), AND INTRAABDOMINAL COLLECTION (N=1). IN CONCLUSION, OUR RESULTS SHOWS THAT THE USE OF KNOTLESS BARBED SUTURE FOR ENTEROTOMY CLOSURE AFTER LAPAROSCOPIC INTRACORPOREAL RIGHT COLECTOMY IS SAFE, REPRODUCIBLE AND ASSOCIATED WITH SHORTER OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610981 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention