BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7326089 · Received March 8, 2018

    Report

    Report Number
    2210968-2018-71360
    Event Type
    Injury
    Date Received
    March 8, 2018
    Report Date
    February 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WHERE WAS THE LOCATION OF THE PSEUDOANEURYSM? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURES USED IN THIS PROCEDURE LEADING TO THE PSEUDOANEURYSM? DOES THE SURGEON BELIEVE THAT ETHICON SUTURES INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? 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.

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLE: COMPARISON OF TWO DIFFERENT SUTURE TECHNIQUES IN LAPAROSCOPIC PARTIAL NEPHRECTOMY. AUTHOR(S): ONUR KAYGISIZ, SINAN ÇELEN, BERNA AYTAC VURUSKAN, HAKAN VURUSKAN. CITATION: INT BRAZ J UROL. 2017; 43: 863-70; DOI: 10.1590/S1677-5538.IBJU.2016.0550. THE AIM OF THE STUDY WAS TO COMPARATIVELY EVALUATE TWO ALTERATIVE RENORRHAPHY TECHNIQUES IN LAPAROSCOPIC PARTIAL NEPHRECTOMY USING MONOCRYL. BETWEEN (B)(6) 2011 AND (B)(6) 2015, 62 CONSECUTIVE PATIENTS (MEAN AGE WAS 57.8±19.5 YEARS) WERE INCLUDED AND ASSIGNED TO TWO GROUPS UNDERGOING LAPAROSCOPIC APPROACH PARTIAL NEPHRECTOMY: GROUP 1 - TRADITIONAL KNOT-TYING SUTURE RENORRHAPHY (N=31; N=22 MALE, N=9 FEMALE) AND GROUP 2 - RUNNING SUTURE TECHNIQUE USING MONOCRYL (N=31; N=18 MALE, 13 FEMALE). IN GROUP 2, OPENED PELVICALYCEAL SYSTEM WAS CLOSED WITH 3-0 VICRYL SUTURES AND INITIAL SUTURE OF RENAL PARENCHYMA WAS ACHIEVED WITH 2-0 MONOCRYL SUTURES AND SIMILARLY WAS USED IN THE TUMOR BED. IN GROUP 2, ONE PATIENT HAD SYMPTOMATIC PSEUDOANEURYSM (LATE BLEEDING) ONE WEEK AFTER THE OPERATION AND UNDERWENT ANGIOGRAPHY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166622 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention