BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 11921066 · Received June 2, 2021

    Report

    Report Number
    2210968-2021-05172
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    November 23, 2018
    Report Date
    May 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS 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. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (SURGICEL, VICRYL SUTURE AND LAPRA-TY ABSORBABLE SUTURE CLIP) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (PSEDOANEURYSM, FEVER, WOUND DEHISCENCE, SEPSIS AND BLEEDING) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (SURGICEL, VICRYL SUTURE AND LAPRA-TY SUTURE CLIP) USED IN THIS PROCEDURE/STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS (PSEDOANEURYSM, FEVER, WOUND DEHISCENCE, SEPSIS AND BLEEDING) AND DETAILS OF EVENTS IF AVAILABLE. WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: UROLOGY (2019); 126: 102-109. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.11.053. ADVERSE EVENTS WERE SUBMITTED VIA 2210968-2021-05029, 2210968-2021-05031, AND 2210968-2021-05173.

    Description of Event or Problem · 1

    TITLE: COMPARING OFF-CLAMP AND ON-CLAMP ROBOT-ASSISTED PARTIAL NEPHRECTOMY: A PROSPECTIVE RANDOMIZED TRIAL THIS PROSPECTIVE RANDOMIZED TRIAL IS TO DETERMINE WHETHER PERFORMING ROBOT-ASSISTED PARTIAL NEPHRECTOMY WITHOUT WARM ISCHEMIA ¿OFF-CLAMP¿ RESULTS IN FAVORABLE POSTOPERATIVE RENAL FUNCTIONAL OUTCOMES COMPARED WITH THE ON-CLAMP METHOD. BETWEEN 2013 TO 2017, A TOTAL OF 80 PATIENTS WITH A SMALL RENAL MASS UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN). 40 PATIENTS (72.5% MALE AND 27.5% FEMALE; MEAN AGE = 59.4 YEARS; MEAN BMI = 31.6) WERE RANDOMIZED TO THE ON-CLAMP GROUP AND 40 PATIENTS (55% MALE AND 45% FEMALE; MEAN AGE = 56.6 YEARS; MEAN BMI = 32.4) TO THE OFF-CLAMP GROUP. SURGERY WAS PERFORMED IN THE ON-CLAMP GROUP BY USING COMPETITOR DEVICES, AND AN INTERRUPTED 0 VICRYL (ETHICON) TO REAPPROXIMATE THE RENAL CAPSULE AND LAPRA-TY CLIPS (ETHICON) TO SECURE ITS PLACE. IN THE OFF-CLAMP GROUP, SURGICEL (ETHICON) OR OTHER METHOD WAS USED IF BRISK BLEEDING WAS ENCOUNTERED. REPORTED COMPLICATIONS 30-D COMPLICATION RATE (N=?); 30-D MAJOR COMPLICATION RATE (N=?); PSEUDOANEURYSM (N=2); FEVER (N=1); POSTOPERATIVE BLEEDING (N=2) REQUIRING BLOOD TRANSFUSION IN ONE PATIENT IN THE ON-CLAMP GROUP WHILE BLOOD TRANSFUSION AND EMBOLIZATION IN ONE PATIENT IN THE OFF-CLAMP GROUP; WOUND DEHISCENCE (N=1); AND SEPSIS (N=1). IN CONCLUSION, IN PATIENTS WITH NORMAL RENAL FUNCTION, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT OFF-CLAMP RAPN RESULTS IN LESS RENAL FUNCTIONAL LOSS WHEN COMPARED WITH THE ON-CLAMP TECHNIQUE. OTHER PERIOPERATIVE OUTCOMES ARE COMPARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816535 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention