BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPULSE POWERSUITE

    MDR report key: 19306958 · Received May 13, 2024

    Report

    Report Number
    2124215-2024-28849
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 24, 2024
    Report Date
    July 11, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF FEVER, EROSION, HEMATURIA, PAIN AND INFECTION WITH SUBSEQUENT EVENT OF MEDICATION REQUIRED ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF FLEXIBLE URETEROSCOPY (FURS) FOR THE TREATMENT OF BILATERAL UPPER URINARY TRACT STONES. A TOTAL OF 121 PATIENTS WITH BILATERAL UPPER URINARY TRACT STONES UNDERWENT, CONSISTING OF 73 PATIENTS IN THE TDS < 30MM GROUP AND 48 PATIENTS IN THE TDS > 30MM GROUP. THE MEAN BILATERAL STONE SIZE WAS 28.2 + 12.2MM (RANGE: 9.1-38.4MM), WITH A MEAN OPERATING TIME OF 97.1 + 39.6MIN (RANGE: 19-220MIN). THE SFR WAS 54.5% AFTER THE FIRST FURS, THE SFR INCREASED TO 97.5% AFTER RE-FURS FOR RESIDUAL STONES. THE OPERATION TIME FOR THE TDS > 30MM GROUP WAS LONGER THAN THAT OF THE TDS < 30MM GROUP (85.1 + 36.5 VS. 115.4 +37.4MIN, P < 0.001). THE SFR AFTER THE FIRST FURS WAS SIGNIFICANTLY LOWER IN THE TDS > 30MM GROUP THAN IN THE TDS < 30MM GROUP (25.0% VS. 73.9%, P < 0.001). ALTHOUGH THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN OVERALL SFR BETWEEN THE TWO GROUPS (93.7% VS. 100%, P = 0.060), THE RATE OF RE-FURS FOR RESIDUAL STONES WAS HIGHER IN THE TDS > 30MM GROUP THAN IN THE TDS < 30MM GROUP (75% VS. 26%, P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES IN LENGTH OF HOSPITAL STAY. THE RESULTS SUGGESTED THAT THE FURS CAN BE EFFECTIVELY PERFORMED WITH A LOW COMPLICATION RATE. A HIGHER SFR AFTER THE FIRST FURS CAN BE ACHIEVED IN THE CASE OF BILATERAL UPPER URINARY TRACT STONES WITH TDS LESS THAN OR EQUAL TO 30MM. THE FACTORS POSTOPERATIVE WERE FEVER, URETERAL MUCOSAL EROSION WITHOUT SMOOTH MUSCLE INJURY, GROSS HEMATURIA, PAIN REQUIRING ANALGESIA AND URINARY TRACT INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF FLEXIBLE URETEROSCOPY (FURS) FOR THE TREATMENT OF BILATERAL UPPER URINARY TRACT STONES. A TOTAL OF 121 PATIENTS WITH BILATERAL UPPER URINARY TRACT STONES UNDERWENT, CONSISTING OF 73 PATIENTS IN THE TDS < 30MM GROUP AND 48 PATIENTS IN THE TDS > 30MM GROUP. THE MEAN BILATERAL STONE SIZE WAS 28.2 + 12.2MM (RANGE: 9.1 - 38.4MM), WITH A MEAN OPERATING TIME OF 97.1 + 39.6MIN (RANGE: 19 - 220MIN). THE SFR WAS 54.5% AFTER THE FIRST FURS, THE SFR INCREASED TO 97.5% AFTER RE-FURS FOR RESIDUAL STONES. THE OPERATION TIME FOR THE TDS > 30MM GROUP WAS LONGER THAN THAT OF THE TDS < 30MM GROUP (85.1 + 36.5 VS. 115.4 + 37.4MIN, P < 0.001). THE SFR AFTER THE FIRST FURS WAS SIGNIFICANTLY LOWER IN THE TDS > 30MM GROUP THAN IN THE TDS < 30MM GROUP (25.0% VS. 73.9%, P < 0.001). ALTHOUGH THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN OVERALL SFR BETWEEN THE TWO GROUPS (93.7% VS. 100%, P = 0.060), THE RATE OF RE-FURS FOR RESIDUAL STONES WAS HIGHER IN THE TDS > 30MM GROUP THAN IN THE TDS < 30MM GROUP (75% VS. 26%, P < 0.001). THERE WERE NO SIGNIFICANT DIFFERENCES IN LENGTH OF HOSPITAL STAY. THE RESULTS SUGGESTED THAT THE FURS CAN BE EFFECTIVELY PERFORMED WITH A LOW COMPLICATION RATE. A HIGHER SFR AFTER THE FIRST FURS CAN BE ACHIEVED IN THE CASE OF BILATERAL UPPER URINARY TRACT STONES WITH TDS < 30MM. THE FACTORS POSTOPERATIVE WERE FEVER, URETERAL MUCOSAL EROSION WITHOUT SMOOTH MUSCLE INJURY, GROSS HEMATURIA, PAIN REQUIRING ANALGESIA AND URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661291 VERSAPULSE POWERSUITE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-VPPS_SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other