BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10547101 · Received September 17, 2020

    Report

    Report Number
    2210968-2020-07026
    Event Type
    Injury
    Date Received
    September 17, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 9/24/2020. CORRECTED INFORMATION: ¿ IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2020-07026 IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE CASES DISCUSSED WERE NOT PREVIOUSLY REPORTED TO ETHICON. THE SURGEON DOES NOT BELIEVE THAT ETHICON PRODUCTS INVOLVED (VICRYL SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE. THERE WAS NO DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). DATE SENT TO THE FDA: 09/17/2020. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. -WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. -DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (VICRYL SUTURE) 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 (VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: ALI ET AL. AFR J UROL (2019) 25:8; DOI: HTTPS://DOI.ORG/10.1186/S12301-019-0003-4. 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: STONE-FREE RATE AFTER SEMIRIGID URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY VERSUS LAPAROSCOPIC URETEROLITHOTOMY FOR UPPER URETERAL CALCULI: A MULTICENTER STUDY THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE STONE-FREE RATE AND POSTOPERATIVE OUTCOMES BETWEEN SEMIRIGID URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY AND LAPAROSCOPIC URETEROLITHOTOMY FOR THE MANAGEMENT OF LARGE UPPER URETERAL STONES. BETWEEN JANUARY 2014 AND MARCH 2017, 67 PATIENTS WITH SOLITARY UPPER URETERAL STONE WHO HAD LAPAROSCOPIC URETEROLITHOTOMY (LU) OR SEMIRIGID URETEROSCOPY AND HOLMIUM LASER LITHOTRIPSY WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP A (MALE=20, FEMALE=17; MEAN AGE=39.4 ± 6.3 YEARS, AGE RANGE= 29 ¿ 55 YEARS) WHICH WERE TREATED BY SEMIRIGID URETEROSCOPY AND LASER LITHOTRIPSY; GROUP B (MALE=17, FEMALE=13; MEAN AGE=42.7 ± 7.2 YEARS, AGE RANGE= 31 ¿ 55 YEARS) WHICH WERE TREATED BY LU. DURING THE PROCEDURE, 4/0 VICRYL SUTURE (ETHICON) WAS USED TO CLOSE THE URETEROTOMY. IN GROUP B, A 5 MM HARMONIC SHEAR (ETHICON) WAS USED TO DISSECT AND REFLECT THE COLON. REPORTED COMPLICATIONS INCLUDED GRADE II URINARY TRACT INFECTION (UTI) (N=4) WHICH WAS TREATED BY ANTIBIOTICS ACCORDING TO URINE CULTURE AND SENSITIVITY RESULTS; AND GRADE I MACROSCOPIC HEMATURIA (N=4) WHICH WAS MANAGED CONSERVATIVELY. IN CONCLUSION, THE STONE-FREE RATES AFTER SEMIRIGID URETEROSCOPY (URS) AND LASER LITHOTRIPSY ARE COMPARABLE TO THOSE FOLLOWING LU, ESPECIALLY WHEN FLEXIBLE URS IS USED TO MANAGE MIGRATING STONE FRAGMENTS AT THE SAME SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013977 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention