BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 12042844 · Received June 22, 2021

    Report

    Report Number
    3003790304-2021-00109
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    January 18, 2021
    Report Date
    September 1, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT ADDITIONAL INFORMATION REPORTED BY THE CUSTOMER. D10: CONCOMITANT DEVICES: URS SEMI-RIGID/GUIDE SENSOR/PIGTAIL (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT INVESTIGATION FINDINGS. DEVICE HISTORY RECORD (DHR)/SERVICE HISTORY REVIEW: A DHR REVIEW HAS BEEN PERFORMED FOR THIS PRODUCT AND DETERMINED THAT THERE WERE NO NONCONFORMANCE'S DURING THE MANUFACTURING PROCESS OF THIS DEVICE. PHYSICAL DEVICE INSPECTION: THE PRODUCT WAS NOT RETURNED, AND NO PICTURES HAVE BEEN PROVIDED, THEREFORE A PHYSICAL INSPECTION OF THE DEVICE COULD NOT BE PERFORMED. EVALUATION/ANALYSIS: THE CUSTOMER WAS NOT PROVIDED AN UPDATED IFU BEYOND THE INITIAL SOFTWARE VERSION 1.0 REVISION. THE LASER CONSOLE HAS SINCE BEEN UPDATED TO SOFTWARE VERSION 2.1. THE CUSTOMER DOES NOT APPEAR TO HAVE BEEN NOTIFIED OF THE FIELD SAFETY CORRECTIVE ACTION AS THE UNIT WAS NOT AT THE CUSTOMER LOCATION UP ON RELEASE OF THE FIELD SAFETY CORRECTIVE ACTION WHICH WOULD HAVE ALSO INFORMED THEM ABOUT THE CHANGES TO THE CONSOLES. THE CUSTOMER IS CURRENTLY NOT USING THIS CONSOLE AND WILL RECEIVE TRAINING AND AN UPDATED IFU UPON BEING WILLING TO USE THE PRODUCT AGAIN. CONCLUSION: THE OEM PERFORMED AN INVESTIGATION AND IS A RESULT OF THE FOLLOWING INFORMATION. THE OEM DETERMINED THAT THE MOST LIKELY FACTOR CONTRIBUTING TO THE OBSERVED CLINICAL OUTCOME WAS EXCESSIVELY HIGH AVERAGE POWER, POSSIBLY AGGRAVATED BY INADEQUATE IRRIGATION. AS A RESULT, BULK TEMPERATURE IN THE URETER WAS ELEVATED ABOVE SAFE LEVELS, WHICH, IN TURN, LED TO CONTRACTION OF THE PASSAGE AND URETERAL STENOSIS THE MANNER IN WHICH SOLTIVE SYSTEM WAS EMPLOYED CONSTITUTES MISUSE, SINCE IT DIRECTLY CONTRADICTS RECOMMENDATIONS OF THE DEVICE MANUAL PROVIDED TO THE CUSTOMER WITH THE DEVICE (EXCEEDING RECOMMENDED SETTINGS).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: SIZE OF STONE: 6MM. LOCATION OF STONE: PELVIS. STENOSIS LENGTH: 1 (UNIT OF MEASURE NOT PROVIDED). THE PATIENT EXPERIENCED URETERAL INJURY AND EXTRAVASATION. DATE STENOSIS DIAGNOSED: (B)(6) 2021. OUTCOME AFTER DILATION: RECURRENCE OF STENOSIS: WAITING FOR THE RESULT OF THE SECOND DILATATION (DATE NOT PROVIDED).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED AN UNSPECIFIED TIME AFTER A URETERO-RENOSCOPY (URS) PROCEDURE (TO TREAT PELVIC CALCULI) USING A SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM, THE PATIENT DEVELOPED URETERAL STENOSIS. A URETERAL DILATION PROCEDURE WAS PERFORMED TO TREAT THE STENOSIS. THE LASER SETTINGS USED FOR THIS PROCEDURE WERE: 10:31 AM 1:37 MM:SS 36657, 1.941 KJ, 20 W, 200-400 HZ, S-M, 021820-1202, 200S. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS FACILITY REPORTS EIGHT CASES IN WHICH THE URETERAL STENOSIS HAS OCCURRED AFTER A URS PROCEDURE USING THIS LASER MACHINE (OUT OF 180 PROCEDURES PERFORMED WITH THIS LASER). THE FACILITY REPORTS NOT ALL OF THESE CASES OF URETERAL STENOSIS WERE DUE TO THE SOLTIVE LASER ALONE, SOME PATIENTS HAD LARGE OR LONG-STANDING STONES IN THE URETER. CASE WITH PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940164 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R