BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 13043138 · Received December 20, 2021

    Report

    Report Number
    2210968-2021-12754
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    August 4, 2020
    Report Date
    January 31, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 1/31/2022. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WE CANNOT RELATE THESE COMPLICATIONS TO THE SUTURE USED DURING THE PROCEDURES.

    Additional Manufacturer Narrative · 0

    (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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: E U R O P E A N U R O L O G Y 7 9 ( 2 0 2 1 ) 8 5 8 ¿ 8 6 5. HTTPS://DOI.ORG/10.1016/J.EURURO.2020.08.0050302-2838.

    Description of Event or Problem · 0

    TITLE: ROBOT-ASSISTED SUPRATRIGONAL CYSTECTOMY AND AUGMENTATION CYSTOPLASTY WITH TOTALLY INTRACORPOREAL RECONSTRUCTION IN NEUROUROLOGICAL PATIENTS: TECHNIQUE DESCRIPTION AND PRELIMINARY RESULTS THIS PROSPECTIVE STUDY AIMS TO REPORT THE FEASIBILITY AND SAFETY OF A STANDARDIZED TECHNIQUE OF ROBOT-ASSISTED SUPRATRIGONAL CYSTECTOMY AND AUGMENTATION CYSTOPLASTY (RASCAC) WITH TOTAL INTRACORPOREAL RECONSTRUCTION, AND TO REPORT THE PERIOPERATIVE AND 1-YR FUNCTIONAL OUTCOMES OBTAINED WITH THIS TECHNIQUE. FROM AUGUST 2016 TO APRIL 2018, 10 CONSECUTIVE PATIENTS (7 MALES AND 3 FEMALES) WITH MEDIAN (IQR) AGE OF 44 (28¿58) YR, WITH REFRACTORY NEUROGENIC DETRUSOR OVERACTIVITY WERE PROSPECTIVELY SELECTED AFTER PROVIDING WRITTEN INFORMED CONSENT TO UNDERGO ROBOT-ASSISTED SUPRATRIGONAL CYSTECTOMY AND AUGMENTATION CYSTOPLASTY (RASCAC) IN A FRENCH TERTIARY REFERRAL CENTER . DURING SURGERY, THE BOWEL IS CONNECTED TO THE POSTERIOR MARGIN OF THE REMAINING BLADDER USING A 3-0 VICRYL STITCH. A SECOND ONE IS PERFORMED 20 CM PROXIMAL TO THE FIRST INCISION, AND THE BOWEL IS CONNECTED TO THE BLADDER IN THE SAME FASHION AS BEFORE . THIS ALLOWS A BETTER EXPOSURE FOR SUBSEQUENT RECONFIGURATION. AT THIS POINT, THE INTESTINAL SEGMENT IS DIVIDED 10 CM DISTALLY FROM THE FIRST INCISION AND 10 CM PROXIMALLY TO THE SECOND ONE USING AN ECHELON ENDOGIA STAPLER (ETHICON). THE CONTINUITY OF THE SMALL BOWEL IS THEN RESTORED THROUGH A LATEROLATERAL ANASTOMOSIS PERFORMED WITH THE SAME STAPLER. ALL PATIENTS WERE FOLLOWED UP MINIMUM OF 1-YR BY A MULTIDISCIPLINARY NEUROUROLOGY TEAM COMPRISING UROLOGISTS, REHABILITATION PHYSICIANS, AND DEDICATED NURSES AND PERFORMED A FIRST CLINICAL ASSESSMENT, 3 MO AFTER SURGERY, FOLLOWED BY A 3-D VOIDING DIARY, COMPLETE URODYNAMIC STUDY, KIDNEY ULTRASOUND, ASSESSMENT OF RENAL FUNCTION, AND CYSTOSCOPY AT 12 MO. REPORTED COMPLICATION INCLUDED: FOUR PATIENTS EXPERIENCED COMPLICATIONS AT 30-D FOLLOW- UP: (N=2) PATIENTS PRESENTED A SYMPTOMATIC LOWER URINARY TRACT INFECTION AFTER REMOVING THE FOLEY CATHETER (CLAVIEN II). (N=2) PARALYTIC ILEUS WAS OBSERVED IN OTHER TWO (CLAVIEN II) .(N=2) DETRUSOR OVERACTIVITY. IT WAS CONCLUDED, THAT ROBOT-ASSISTED AUGMENTATION CYSTOPLASTY HAS BEEN SHOWN TO BE SAFE AND FEASIBLE, WITH A REASONABLE OPERATIVE TIME AND LOW COMPLICATION RATE IN EXPERIENCED HANDS. A HIGHER NUMBER OF PATIENTS AND LONGER FOLLOW-UP ARE, HOWEVER, WARRANTED TO DRAW DEFINITIVE CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940055 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown