BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15026493 · Received July 15, 2022

    Report

    Report Number
    2210968-2022-05527
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    January 7, 2022
    Report Date
    July 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. 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. RELATED EVENTS CAPTURED VIA 2210968-2022-05527, 2210968-2022-05528 AND 2210968-2022-05529. CITATION: HTTPS://DOI.ORG/10.1016/J.EURURO.2022.01.007.

    Description of Event or Problem · 0

    TITLE: ROBOTIC-ASSISTED LINGUAL MUCOSAL GRAFT URETEROPLASTY FOR THE REPAIR OF COMPLEX URETERAL STRICTURES: TECHNIQUE DESCRIPTION AND THE MEDIUM-TERM OUTCOME. THE AIM OF THIS PROSPECTIVE STUDY IS TO REPORT THE MEDIUM-TERM OUTCOME OF ROBOTIC URETEROPLASTY WITH A LINGUAL MUCOSAL GRAFT (RU-LMG) FOR MANAGING COMPLEX URETERAL STRICTURES. BETWEEN JUNE 2019 AND SEPTEMBER 2020, 12 PATIENTS (7 MALES AND 5 FEMALES; MEDIAN AGE OF 31 YEARS [RANGE 24-66]; MEAN BMI OF 24.3 [17-31] KG/M2) WHO UNDERWENT RU-LMG WERE INCLUDED. INDICATIONS FOR SURGERY INCLUDED PERSISTENT CLINICAL SYMPTOMS, RENAL FUNCTION DETERIORATION, AND OBSTRUCTION EVIDENCED BY RADIOGRAPHIC RESULTS. SIX PATIENTS (50%) UNDERWENT POSTERIORLY AUGMENTED ANASTOMOSIS WITH LMG VENTRAL ONLAY URETEROPLASTY. THE OTHER PATIENTS (50%) UNDERWENT ONLY LMG VENTRAL ONLAY URETEROPLASTY (TABLE 2). IN THE POSTERIORLY AUGMENTED ANASTOMOTIC TECHNIQUE, 5-0 VICRYL OR 5-0 MONOCRYL SUTURES WERE OFTEN USED. AFTER HARVESTING THE LMG, THE DONOR SITE WAS CLOSED WITH RUNNING OR INTERRUPTED 3-0 OR 4-0 VICRYL SUTURES. AT THE TWO ENDS OF THE LMG, 5-0 VICRYL OR MONOCRYL SUTURES WERE OFTEN USED TO FIX THE GRAFT TO AVOID CRIMPING THE LMG (FIG. 5B AND 5C). IT WAS USEFUL TO KEEP A STRAIGHT EDGE OF THE GRAFT TO FACILITATE ANASTOMOSIS IN A RUNNING FASHION (FIG. 5D AND 5E). MOREOVER, A WATERTIGHT AND TENSION-FREE ANASTOMOSIS WAS NECESSARY (FIG. 5F). THEREFORE, AFTER COMPLETING THE ANASTOMOSIS, A SALINE SOLUTION WAS INJECTED FROM THE NEPHROSTOMY TUBE TO CHECK THE WATERTIGHT EDGE OF THE ANASTOMOSIS. THE REPAIRED URETERAL SEGMENT WAS WRAPPED WITH A WELL-VASCULARIZED PEDICLED OMENTUM (FIG. 5G AND 5H). THE OMENTAL FLAP WAS FIXED TO THE PSOAS MUSCLE WITH 3-0 ABSORBABLE BARBED SUTURES (STRATAFIX; ETHICON, USA; FIG. 5G AND 5H). FINALLY, A DRAINAGE TUBE WAS PLACED NEAR THE ANASTOMOTIC AREA. REPORTED COMPLICATIONS INCLUDE FEVER AND URINARY TRACT INFECTION (N=1) REQUIRING PROLONGED INTRAVENOUS ANTIBIOTIC THERAPY; AND INTERMITTENT TONGUE NUMBNESS AT THE LMG DONOR SITE (N=1) WHICH DID NOT AFFECT HER SPEECH OR EATING AND THIS FEELING GRADUALLY FADED AWAY. IN CONCLUSIONS, THESE MEDIUM-TERM FOLLOW-UP RESULTS DEMONSTRATE THAT RU-LMG IS A SAFE AND FEASIBLE TECHNIQUE FOR REPAIRING URETERAL STRICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722261 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention