BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14279537 · Received May 4, 2022

    Report

    Report Number
    8010047-2022-07525
    Event Type
    Injury
    Date Received
    May 4, 2022
    Report Date
    July 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, H6, H10. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "EVALUATING THE EFFECT OF INJECTING TRIAMCINOLONE ACETONIDE IN TWO SESSIONS FOR PREVENTING ESOPHAGEAL STRICTURE AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THE STUDY INVESTIGATED THE EFFICACY OF INJECTING TRIAMCINOLONE ACETONIDE (TA) IN TWO SESSIONS FOR PREVENTING STRICTURE FORMATION POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE PRIMARY ENDPOINT OF THIS STUDY WAS FREQUENCY OF STRICTURE AFTER TA INJECTION. THE SECONDARY ENDPOINT WAS NUMBER OF REQUIRED ENDOSCOPIC BALLOON DILATIONS (EBDS) AFTER TA INJECTION. THE POST-ESD STRICTURE RATE AMONG PATIENTS WHO HAD SUBCIRCUMFERENTIAL MUCOSAL DEFECTS WAS 45.7% IN THE STUDY GROUP (16/35 PATIENTS), WHICH WAS SIGNIFICANTLY LOWER THAN THE RATE OF 73.9% IN THE CONTROL GROUP (17/23 PATIENTS; P = 0.031). THE NUMBER OF EBD PROCEDURES REQUIRED WAS SIGNIFICANTLY LOWER IN THE STUDY GROUP (MEDIAN 0, RANGE 0-7) THAN IN THE CONTROL GROUP (MEDIAN 4, RANGE 0-20; P < 0.001). THIS STUDY SHOWED THAT PERFORMING TWO SESSIONS OF TA INJECTION IS AN EFFECTIVE AND SAFE TREATMENT FOR PREVENTION OF ESOPHAGEAL STRICTURE FOLLOWING SUBCIRCUMFERENTIAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: SUBCIRCUMFERENTIAL MUCOSAL DEFECTS. STUDY GROUP: PERFORATIONS AFTER EBD AT 22 AND 77 DAYS AFTER ESD-(2). CONTROL GROUP: PERFORATIONS AFTER EBD AT 36 DAYS AFTER ESD-(1). CIRCUMFERENTIAL MUCOSAL DEFECTS. CONTROL GROUP: PERFORATION AFTER EBD WAS RECOGNIZED AT 7 DAYS AFTER ESD IN 1 PATIENT. THIS ARTICLE INCLUDES 4 REPORTS: (B)(6): KD-620LR. (B)(6): FD-410LR. (B)(6): GIF-Q240. (B)(6): GIF-Q260J. THIS REPORT IS 3 OF 4 FOR (B)(6): GIF-Q240.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS. THE AUTHOR STATED: ¿I DON'T KNOW IF THE POSSIBILITY IS ZERO, BUT I DON'T THINK THAT THERE IS A PROBLEM WITH THE DEVICES.¿ ADDITIONALLY, THE AUTHOR REPORTED THAT NO OLYMPUS DEVICES HAD MALFUNCTIONED DURING ANY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243000 EVIS GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q240

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other KD-620LR,FD-410LR.