BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12566022 · Received October 1, 2021

    Report

    Report Number
    2210968-2021-09103
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    May 19, 2020
    Report Date
    September 16, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATION (URINARY TRACT INFECTION) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED AND DESCRIBED IN THIS STUDY? -IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPERIENCED THE POST-OPERATIVE COMPLICATION (URINARY TRACT INFECTION)? WAS THIS CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION CITE:UROLOGY 143: 147-152, 2020. © 2020 ELSEVIER INC.; HTTPS://DOI.ORG/10.1016/J.UROLOGY.2020.05.041. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: SINGLE-PORT ROBOT-ASSISTED DISMEMBERED PYELOPLASTY WITH MINI- PFANNENSTIEL OR PERI-UMBILICAL ACCESS: INITIAL EXPERIENCE IN A SINGLE CENTER. THE OBJECTIVE OF THIS STUDY WAS TO ASSESS THE FEASIBILITY AND DESCRIBE THE SURGICAL TECHNIQUE FOR SINGLE-PORT ROBOTIC-ASSISTED LAPAROSCOPIC PYELOPLASTY USING THE NEW DA VINCI SP SURGICAL PLATFORM (INTUITIVE SURGICAL INC., SUNNYVALE, CA), AND TO DESCRIBE THE APPROACH THROUGH A MINI-PFANNENSTIEL INCISION. FROM OCTOBER 2018 THROUGH OCTOBER 2019, PERIOPERATIVE DATA OF 10 CONSECUTIVE PATIENTS WITH A DIAGNOSIS OF URETEROPELVIC JUNCTION OBSTRUCTION UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC PYELOPLASTY WITH THE DA VINCI SP SURGICAL PLATFORM IN A SINGLE HIGH-VOLUME ROBOTIC SURGERY INSTITUTION AND WERE ENTERED IN AN IRB-APPROVED DATABASE. PYELOPLASTY WAS PERFORMED WITH THE DA VINCI SP SYSTEM THROUGH A PURE SINGLE SITE APPROACH (EXCEPT FOR THE FIRST PATIENT). THE INITIAL PROCEDURES WERE PERFORMED THROUGH A MIDLINE INCISION AND THE TECHNIQUE EVOLVED TO A MINI-PFANNENSTIEL INCISION. THE ANASTOMOSIS IS COMPLETED USING 4-0 VICRYL SUTURE (ETHICON). REPORTED COMPLICATION INCLUDED POST-OPERATIVE URINARY TRACT INFECTION (N=1) TREATED WITH ANTIBIOTICS. IN CONCLUSION SINGLE-PORT ROBOTIC-ASSISTED LAPAROSCOPIC PYELOPLASTY IS A SAFE AND FEASIBLE PROCEDURE THROUGH A MINI-PFANNENSTIEL INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462471 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention