BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 20279413 · Received September 23, 2024

    Report

    Report Number
    9610595-2024-18967
    Event Type
    Injury
    Date Received
    September 23, 2024
    Report Date
    November 13, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170156120
    PMA / PMN Number
    K011151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000412. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 EVENTS 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 REVIEWED THE FOLLOWING LITERATURE TITLED ¿SAFETY, EFFICACY, AND CLINICAL UTILITY OF THE 5.1-MM DEBRIDEMENT CATHETER FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS.¿ A MULTICENTER COHORT STUDY WAS CONDUCTED AT 8 INSTITUTIONS INCLUDING PATIENTS WHO UNDERWENT DIRECT ENDOSCOPIC NECROSECTOMY (DEN) WITH THE 5.1-MM ENDOROTOR. THE PRIMARY OUTCOME WAS THE NUMBER OF DEN SESSIONS NEEDED FOR WALLED-OFF NECROSIS (WON) RESOLUTION. SECONDARY OUTCOMES WERE THE AVERAGE PERCENTAGE OF REDUCTION IN SOLID WON DEBRIS AND DECREASE IN WON AREA PER SESSION, TOTAL TIME SPENT PERFORMING ENDOROTOR THERAPY FOR WON RESOLUTION, AND ADVERSE EVENTS (AES). DIRECT ENDOSCOPIC NECROSECTOMY (DEN) IS A RECOMMENDED STRATEGY FOR TREATMENT OF WALLED-OFF NECROSIS (WON). DEN USES A VARIETY OF DEVICES INCLUDING THE ENDOROTOR (INTERSCOPE, INC, NORTHBRIDGE, MASS, USA) DEBRIDEMENT CATHETER. RECENTLY, A 5.1-MM ENDOROTOR WITH AN INCREASED CHAMBER SIZE AND RATE OF TISSUE REMOVAL WAS INTRODUCED. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF THIS DEVICE. A MULTICENTER COHORT STUDY WAS CONDUCTED AT 8 INSTITUTIONS INCLUDING PATIENTS WHO UNDERWENT DEN WITH THE 5.1-MM ENDOROTOR. THE PRIMARY OUTCOME WAS THE NUMBER OF DEN SESSIONS NEEDED FOR WON RESOLUTION. SECONDARY OUTCOMES WERE THE AVERAGE PERCENTAGE OF REDUCTION IN SOLID WON DEBRIS AND DECREASE IN WON AREA PER SESSION, TOTAL TIME SPENT PERFORMING ENDOROTOR THERAPY FOR WON RESOLUTION, AND ADVERSE EVENTS (AES). RESULTS: SIXTY-FOUR PROCEDURES IN 41 PATIENTS WERE INCLUDED. FOR PATIENTS IN WHICH THE 5.1-MMENDOROTOR CATHETER WAS THE SOLE THERAPEUTIC MODALITY, AN AVERAGE OF 1.6DENSESSIONS RESULTED IN WON RESOLUTION WITH AN AVERAGE CUMULATIVE TIME OF 85.5 MINUTES. OF THE 21 PROCEDURES WITH DATA REGARDING PERCENTAGE OF SOLID DEBRIS, THE AVERAGE REDUCTION WAS 85% 23%PER SESSION. OF THE 19 PROCEDURES WITH DATA REGARDING WON AREA, THE MEAN AREA SIGNIFICANTLY DECREASED FROM 97.6 72.0 CM2 TO 27.1 35.5 CM2 (P < .001) PER SESSION. AES INCLUDED 2 INTRAPROCEDURAL DISLODGEMENTS OF LUMEN-APPOSING METAL STENTS MANAGED ENDOSCOPICALLY AND 3 PERFORATIONS, NONE OF WHICH WAS RELATED TO THE ENDOROTO BUT RATHER THE DOUBLE PIG TAIL AND/OR THE METAL STENT REMOVAL. BLEEDING WAS REPORTED IN 7 CASES, ALL OF WHICH WERE TREATED ENDOSCOPICALLY. NONE OF THESE CASES REQUIRED EMBOLIC OR SURGICAL THERAPY; HOWEVER, 2 REQUIRED BLOOD TRANSFUSIONS. CONCLUSIONS: THIS IS THE FIRST MULTICENTER RETROSPECTIVE STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF THE 5.1-MM ENDOROTOR CATHETER FOR WON. RESULTS FROM THIS STUDY SHOWED AN AVERAGE OF 1.6 DEN SESSIONS WERE NEEDED TO ACHIEVE WON RESOLUTION WITH AN 85% SINGLE-SESSION REDUCTION IN SOLID DEBRIS AND A 70% SINGLE-SESSION DECREASE IN WON AREA WITH MINIMAL AES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487770 EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XTQ160 04953170156120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ENDOROTOR, INTERSCOPE INC