BEUDAMED
    FDA Adverse Event Injury Summary report: N

    150 MICRON TFL BALL TIP SINGLE USE FIBER

    MDR report key: 17168119 · Received June 20, 2023

    Report

    Report Number
    3003790304-2023-00242
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    February 26, 2023
    Report Date
    September 13, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - CODE 4581 IS USED TO REPRESENT URINE LEAKAGE, URETERAL INJURY, CLAVIEN GRADE I-IV, AND PYELONEPHRITIS. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE LITERATURE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT B3. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PROSPECTIVE COMPARISON OF THULIUM AND HOLMIUM LASER LITHOTRIPSY FOR THE TREATMENT OF UPPER URINARY TRACT LITHIASIS". LITERATURE SUMMARY THIS WAS A PROSPECTIVE SINGLE-CENTER STUDY WAS TO COMPARE THE PERFORMANCE AND COMPLICATIONS BETWEEN HOLMIUM:YTTRIUM-ALUMINUM-GARNET (HO:YAG) AND THULIUM FIBER LASER (TFL) FOR UPPER URINARY TRACT (UUT) LITHOTRIPSY. A TOTAL OF 176 (76 HO:YAG LITHOTRIPSY AND 100 TFL) WERE INCLUDED. THE MEAN CUMULATIVE STONE SIZE (20.4 VS 14.8 MM; P = 0.01) AND MEAN DIAMETER OF THE LARGEST STONE (14.6 VS 11.6 MM; P = 0.01) WERE SIGNIFICANTLY GREATER IN THE TFL THAN IN THE HO:YAG. POSTOPERATIVE PAIN WAS SIMILAR IN THE TWO GROUPS. IN THE TFL GROUP, USE OF STONE BASKETS WAS SIGNIFICANTLY LESS FREQUENT (55% VS 90%; P < 0.001). THE SF RATE WAS SIMILAR IN THE TFL AND HO:YAG GROUPS (72% VS 68.4%; P = 0.06). OPERATIVE TIME WAS SHORTER IN THE TFL THAN IN THE HO:YAG GROUP (56.6 VS 65.6 MIN; P = 0.04). TFL IS AN EFFECTIVE AND SAFE LASER FOR URS TREATMENT OF UUT LITHIASIS. BACKGROUND: LITHOTRIPSY WITH HOLMIUM:YTTRIUM-ALUMINUM-GARNET (HO:YAG) LASER IS THE CURRENT GOLD STANDARD FOR TREATING STONES OF THE UPPER URINARY TRACT (UUT). THE RECENTLY INTRODUCED THULIUM FIBER LASER (TFL) HAS THE POTENTIAL TO BE MORE EFFICIENT AND AS SAFE AS HO:YAG. OBJECTIVE: TO COMPARE THE PERFORMANCE AND COMPLICATIONS BETWEEN HO:YAG AND TFL FOR UUT LITHOTRIPSY. DESIGN, SETTING, AND PARTICIPANTS: THIS WAS A PROSPECTIVE SINGLE-CENTER STUDY OF 182 PATIENTS TREATED BETWEEN (B)(6) 2021 AND (B)(6) 2022. IN A CONSECUTIVE APPROACH, LASER LITHOTRIPSY WAS PERFORMED VIA URETEROSCOPY WITH HO:YAG FOR 5 MONTHS, AND THEN WITH TFL FOR 5 MONTHS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: OUR PRIMARY OUTCOME WAS STONE-FREE (SF) STATUS AT 3 MO AFTER URETEROSCOPY WITH HO:YAG VERSUS TFL LITHOTRIPSY. SECONDARY OUTCOMES WERE COMPLICATION RATES AND RESULTS REGARDING THE CUMULATIVE STONE SIZE. PATIENTS WERE FOLLOWED AT 3 MO WITH ABDOMINAL IMAGING (ULTRASOUND OR COMPUTED TOMOGRAPHY). RESULTS AND LIMITATIONS: THE STUDY COHORT COMPRISED 76 PATIENTS TREATED WITH HO: YAG LASER AND 100 PATIENTS TREATED WITH TFL. CUMULATIVE STONE SIZE WAS SIGNIFICANTLY HIGHER IN THE TFL THAN IN THE HO:YAG GROUP (20.4 VS 14.8 MM; P = 0.01). SF STATUS WAS SIMILAR IN BOTH GROUPS (68.4% VS 72%; P = 0.06). COMPLICATION RATES WERE COMPARABLE. IN SUBGROUP ANALYSIS, THE SF RATE WAS SIGNIFICANTLY HIGHER (81.6% VS 62.5%; P = 0.04) AND THE OPERATIVE TIME WAS SHORTER FOR STONES MEASURING 1¿2 CM, WHEREAS THE RESULTS WERE SIMILAR FOR STONES <1 CM AND >2 CM. THE LACK OF RANDOMIZATION AND SINGLE-CENTER DESIGN ARE THE MAIN LIMITATIONS OF THE STUDY. CONCLUSIONS: TFL AND HO:YAG LITHOTRIPSY ARE COMPARABLE IN TERMS OF THE SF RATE AND SAFETY FOR THE TREATMENT OF UUT LITHIASIS. ACCORDING TO OUR STUDY, FOR A CUMULATIVE STONE SIZE OF 1¿2 CM, TFL IS MORE EFFECTIVE THAN HO:YAG. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS BLEEDING - 2 PATIENTS URINE LEAKAGE -5 PATIENTS URETERAL INJURY - 1 PATIENT CLAVIEN GRADE I¿II - 9 PATIENTS CLAVIEN GRADE III¿V - 4 PATIENTS PYELONEPHRITIS - 5 PATIENTS THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207128 150 MICRON TFL BALL TIP SINGLE USE FIBER POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-FBX150BS UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other