BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12615477 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09538
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    June 30, 2015
    Report Date
    September 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: J ROBOTIC SURG (2015); 9:215¿222. DOI 10.1007/S11701-015-0519-Y. EVENT RELATED TO MW# 2210968-2021-09539.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: ROBOTIC SURGERY AND HEMOSTATIC AGENTS IN PARTIAL NEPHRECTOMY: A HIGH RATE OF SUCCESS WITHOUT VASCULAR CLAMPING AUTHORS: LUCA MORELLI, JOHN MORELLI, MATTEO PALMERI, CRISTIANO D¿ISIDORO, EMANUELE FEDERICO KAUFFMANN, DARIO TARTAGLIA, GIOVANNI CAPRILI, ROBERTA PISANO, SIMONE GUADAGNI, GREGORIO DI FRANCO, GIULIO DI CANDIO, FRANCO MOSCA CITATION: J ROBOTIC SURG (2015); 9:215¿222. DOI 10.1007/S11701-015-0519-Y. THE AIM OF THIS RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATA IS TO DESCRIBE THE AUTHOR'S INITIAL EXPERIENCE OF PERFORMING RPN WITH OR WITHOUT VASCULAR CLAMPING IN COMBINATION WITH SYSTEMATIC USE OF HEMOSTATIC AGENTS. A TOTAL OF 31 PATIENTS [20 MALE AND 11 FEMALE; MEAN AGE OF 65.8 YEARS (RANGE 45-81 YEARS); MEAN BMI OF 25.65 (RANGE 20.2-40.4)] WITH A DIAGNOSIS OF A RENAL MASS ON WHOM A ROBOTIC PARTIAL NEPHRECTOMY WAS PERFORMED FROM FEBRUARY 2009 TO OCTOBER 2014 WERE INCLUDED IN THE STUDY. AFTER REMOVAL OF THE TUMOR, PRIMARY HEMOSTASIS AT THE RESECTION BED WAS MANAGED BY APPLICATION OF A FIBRIN SEALANT (FLOSEAL HEMOSTATIC MATRIX, BAXTER, HEALTHCARE) AND BY COMPRESSION WITH A SURGICAL SPONGE. THE DEFECT WAS FINALLY COVERED WITH A SHEET OF OXIDIZED REGENERATE CELLULOSE (TABOTAMP FIBRILLAR, JOHNSON & JOHNSON; ETHICON, USA). IF THERE WAS FURTHER BLEEDING OR URINE LEAK, PROLENE STICHES WITH OR WITHOUT DACRON PLEDGET WERE USED TO IMPROVE HEMOSTASIS. REPORTED COMPLICATIONS INCLUDE URINARY FISTULA (N=1) WHICH RESOLVED WITH THE PLACEMENT OF A URETERAL STENT, AND THE USE OF PROLENE SUTURES (N=8). IN CONCLUSION, ROBOT-ASSISTED PARTIAL NEPHRECTOMY APPEARS TO BE A SAFE AND EFFECTIVE TECHNIQUE FOR THE SURGICAL MANAGEMENT OF LOCALIZED RENAL MALIGNANCY WHILE PRESERVING ONCOLOGICAL AND CLINICAL GOALS. RECENT ADVANCES OF THE ROBOTIC SYSTEM ITSELF AND THE USE OF HEMOSTATIC AGENTS IMPROVES THE LIKELIHOOD CARRYING OUT A CONSERVATIVE RESECTION WITHOUT ISCHEMIC DAMAGE TO THE KIDNEY IN SELECTED CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515042 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention