BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 19884574 · Received August 1, 2024

    Report

    Report Number
    3011050570-2024-00309
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 1, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL COMPLAINTS CREATED FOR ADDITIONAL PRODUCT FAILURES REPORTED BY THE CONTACT: EVENT DATE: 07JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4) (LASER SYSTEM). EVENT DATE: 11JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4) (LASER SYSTEM). EVENT DATE: 12JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4) (LASER SYSTEM). EVENT DATE: 14JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4) (LASER SYSTEM). EVENT DATE: 17JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4) (LASER SYSTEM). ORIGINAL COMPLAINTS: EVENT DATE: 28JUN2024 - (B)(4) (WIRELESS FOOTSWITCH) AND (B)(4)(LASER SYSTEM). RELATED COMPLAINT: (B)(4) FOR WIRELESS FOOTSWITCH - MODEL TFL-AFSWL - SN (B)(6) CUSTOMER EMAILED OLYMPUS "WE DO NOT HAVE A WIRED FOOTSWITCH. OUR WIRELESS FOOTSWITCH HAS BEEN CAUSING ISSUES. THERE HAS BEEN A DELAY IN CARE. WE HAD OUR REP OUT FOR THIS DUE TO THE FREQUENCY OF THE SURGEON'S STEPPING ON THE PEDAL. I WILL REPORT COMPLAINTS TO THE TAC ON THE LETTER." NO FURTHER INFORMATION PROVIDED INCLUDING PAE ----------- AFTER SALESFORCE REPORT REVIEW, MODEL NUMBER ADDED, SERIAL NUMBER ADDED, PAE Q1 CHANGED TO NO. A BETTER CODE WAS SELECTED ACCORDING WITH EVENT DESCRIPTION AND SALESFORCE REPORT. IT WAS CHANGED FROM 000 - PAE UNKNOWN TO LAA15 - PAE NO. UDI ADDED AFTER GUDID REVIEW. ACTION ITEM OPENED TO REQUEST PRODUCT RETURN INFORMATION, EVENT FOUND AT, PAE QUESTIONNAIRE. (B)(4) 495559/22JUL2024. ---------- ACTION ITEM GA24309176-1 COMPLETED, NEW INFORMATION AVAILABLE: CUSTOMER RESPONSE SUMMARY: 1. ARE YOU PLANNING ON RETURNING THE DEVICE TO OLYMPUS FOR SERVICE? IF SO, CAN YOU PROVIDE A TRACKING NUMBER, AND WHEN DO YOU PLAN ON RETURNING THE DEVICE? PER OLYMPUS REP I SPOKE TO TODAY, FOOTSWITCHES ARE NOT REPAIRABLE. WE HAVE A CORDED FOOTSWITCH ON SITE WE ARE USING. 2. IF YOU'RE NOT PLANNING ON RETURNING THE DEVICE FOR SERVICE, WHAT IS THE REASONING FOR NOT SENDING THE DEVICE TO OLYMPUS? OLYMPUS REP (CHRIS) I SPOKE TO TODAY SAID FOOT SWITCHES ARE NOT REPAIRABLE. 3. WHEN WAS THE PROBLEM FIRST NOTICED? CHOOSE ONE. DURING PROCEDURE. IF THIS EVENT OCCURRED DURING THE PREPARATION FOR USE OR DURING A PROCEDURE, PLEASE ANSWER THE FOLLOWING QUESTIONS: 1. NAME OF PROCEDURE PERFORMED. MULTIPLE PROCEDURES. ALL INVOLVED CYSTOSCOPY WITH LASER LITHOTRIPSY 2. TYPE OF PROCEDURE PERFORMED (CHOOSE ONE) PATIENTS HAD KIDNEY STONES AND NEEDED LASER TO MAKE THEM SMALLER THERAPEUTIC 3. WERE ANY OTHER DEVICES INVOLVED OR REPLACED DURING THE EVENT IN QUESTION? NO 4. WAS THERE ANY DELAY IN THE PROCEDURE IN WHICH THE SUBJECT DEVICE WAS USED? YES 1. IF YES, HOW LONG WAS THE DELAY AND WAS THE PATIENT UNDER GENERAL ANESTHESIA AT THE TIME? YES, MULTIPLE DELAYS AND YES THE PATIENTS WERE UNDER GENERAL ANESTHESIA (ALWAYS UNDER GENERAL ANESTHESIA FOR THIS PROCEDURE) 5. WAS THE INTENDED PROCEDURE COMPLETED? YES 6. WAS THE SAME DEVICE USED TO COMPLETE THE PROCEDURE? YES 7. IF THE DEVICE FAILED DURING A PROCEDURE, WHEN DURING THE PROCEDURE DID THE PRODUCT FAIL? (CHOOSE ONE) MIDDLE 8. IF THE FAILURE EVENT INVOLVED A PATIENT, CAN YOU PROVIDE US WITH ANY PATIENT DEMOGRAPHICS? THIS HAPPENED TO MULTIPLE PATIENTS AND WE DID NOT KEEP A LOG. WE CALLED OUR OLYMPUS REPRESENTATIVE DUE TO THIS HAPPENING MULTIPLE TIMES WHO CAME OUT TO OUR SITE TO OBSERVE BECAUSE THE FOOTSWITCH KEPT FAILING TO WORK 9. WERE THERE ANY ERROR MESSAGES THAT MAY HAVE BEEN OBSERVED BECAUSE OF THE FAILURE? UNKNOWN 10. CAN YOU PROVIDE YOUR JOB TITLE? COMPLIANCE MANAGER IF YOU ARE UNABLE TO PROVIDE THE INFORMATION, PLEASE LET ME KNOW IF THERE IS SOMEONE ELSE THAT I SHOULD REACH OUT TO. (B)(6) IS OUR OLYMPUS REP FOR OUR CENTER ACCORDING WITH INFORMATION PROVIDED, EVENT FOUND AT WAS CHANGED FROM UNKNOWN TO PROCEDURE. SINCE A DELAY WAS STATED, THIS COMPLAINT RECORD IS NOW A TIER 1, PAE Q1 CHANGED TO YES. ACTION ITEM OPENED TO REQUEST INFORMATION REGARDING THE MENTIONED MULTIPLE PROCEDURES WHERE THE FOOTSWITCH WAS INVOLVED. (B)(4) 495559/23JUL2024 .------ ACTION ITEM GA24309176-2 (RELATED TO MULTIPLE PROCEDURES MENTIONED BY CUSTOMER) COMPLETED, CUSTOMER RESPONSE SUMMARY: "YES, WE REPORTED THESE TO OUR AREA OLYMPUS REP WHO CAME OUT AND DID TROUBLESHOOTING WITH THE FOOT SWITCH DURING ACTUAL CASES" NO ADDITIONAL DETAILS WERE PROVIDED. (B)(4) 495559/23JUL2024 ---------- UPDATE: UPDATED REPORTING/CONTACT PERSON (B)(4) POSITION/OCCUPATION TO COMPLIANCE MANAGER TO COMPLIANCE MANAGER PER PAE QUESTIONNAIRE EMAIL RESPONSE. (B)(4) 24JUL2024 ========== UPDATE: CREATED COMPLAINT (B)(4) FOR THE LASER SYSTEM. NEED CONFIRMATION OF THE MODEL NUMBER AND A SERIAL NUMBER. WILL FOLLOW-UP WITH REP AS CONTACT HAS NOT PROVIDED ALL OF THE REQUESTED INFORMATION: MODEL AND SERIAL NUMBER OF LASER SYSTEM, HOW LONG OF A DELAY, EXPERIENCED FOR THE INDIVIDUAL CASES, HOW MANY CASES). (B)(4) 24JUL2024 ========== UPDATE: CALLED AND SPOKE TO CONTACT (B)(4) 29JUL2024 AND SHE SAID THAT SHE DOES NOT HAVE ALL THE CASES WHERE THE WIRELESS FOOT SWITCH FAILED WHILE USING THE LASER SYSTEM. SHE LOOKED IN HER FILES AND PULLED UP THE DAYS THAT THEY HAD UROLOGY CASES: 07JUN2024, 11JUN2024, 12JUN2024, 14JUN2024, 17JUN2024 AND 28JUN2024. I ASKED HOW MANY CASES EACH DAY AND SHE SAID THAT IT WOULD TAKE HOURS TO FIGURE THAT OUT. ALSO, THE OR MANAGER IS ON VACATION THIS WEEK. I ASKED ABOUT THE CONTINUED USE OF THE WIRELESS FOOTSWITCH WITH THE LASER SYSTEM, AND SHE SAID THAT IT WAS THE SURGEON'S PREFERENCE. SHE STATED THAT WHEN THE SURGEONS WOULD LASER A STONE, THEY WOULD STEP ON THE FOOTSWITCH AND IT WOULDN'T WORK, THEY WOULD STEP ON IT AGAIN, AND IT STILL WOULD NOT WORK AND THEN THEY WOULD STEP ON IT THE THIRD TIME, AND IT WOULD WORK. SINCE THEY RECEIVED NOTIFICATION FROM OLYMPUS ON 02JUL2024, THEY EXCLUSIVELY USE THE CORDED FOOTSWITCH. (B)(4) ALSO MENTIONED THAT IN NONE OF THE CASES WAS THERE ANY PATIENT HARM. (B)(4) WILL HAVE TO GO TO THE OR TO SEE OBTAIN THE SERIAL NUMBER FOR THE LASER SYSTEM. (B)(4) 29JUL2024.

    Description of Event or Problem · 0

    IT WAS REPORTS OF THE WIRELESS FOOTSWITCH AND LASER SYSTEM HAD ISSUES DURING PROCEDURE AND SURGEON HAD TO STEP ON THE PEDAL FREQUENTLY. THE SITE REPORTED THIS ISSUE TO OLYMPUS REPRESENTATIVE WHO VISITED THE SITE AND TROUBLESHOOTED THE ISSUE DURING A CASE. THE PROCEDURES WERE CYSTOSCOPY WITH LASER LITHOTRIPSY, WHEREIN THE KIDNEY STONES NEEDED A LASER TO BREAK THEM DOWN. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, THOUGH AN UNSPECIFIED DELAY WAS REPORTED THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119985 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-PLS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown