BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 16090129 · Received January 3, 2023

    Report

    Report Number
    9614641-2023-00006
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    September 14, 2022
    Report Date
    January 26, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDI
    UDI-DI
    04953170298462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 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 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. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO E4 AND G2. INFORMATION ADDED THAT WAS INADVERTENTLY NOT INCLUDED ON PREVIOUS SUBMISSIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDED ADDITIONAL INFORMATION FROM THE AUTHOR (SEE B5).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNDERWATER ENDOSCOPIC SUBMUCOSAL DISSECTION AND HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION AS RESCUE THERAPY IN DIFFICULT COLORECTAL CASES". THIS RETROSPECTIVE ANALYSIS DEMONSTRATES THAT UNDERWATER ESD (U-ESD) AND HYBRID ESD (H-ESD) ARE BOTH EFFECTIVE AND SAFE AS RESCUE THERAPY IN DIFFICULT COLORECTAL ESD. THERE WERE FIFTY-NINE COLORECTAL NEOPLASMS WERE CONSIDERED, 22 OF WHICH WERE REMOVED BY U-ESD AND 37 BY H-ESD. THE EN BLOC RESECTION RATE IN THE U-ESD GROUP WAS 100%, WHILE IT WAS 59.5% IN THE H-ESD GROUP. DISSECTION SPEED WAS 17.7MM2/MIN IN THE U-ESD GROUP AND 8.3MM2/MIN IN THE H-ESD GROUP. THIS STUDY CONCLUDES THAT THE U-ESD AND H-ESD ARE BOTH EFFECTIVE AND SAFE TECHNIQUES IN DIFFICULT COLORECTAL SITUATIONS. U-ESD IS PARTICULARLY EFFECTIVE AND FAST FOR LARGE LESIONS WHEN IT IS NOT POSSIBLE TO OBTAIN COMFORTABLE KNIFE POSITION, WHILE H-ESD IS MORE SUITABLE FOR VERY FIBROTIC LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS [UNDERWATER ESD], BACTEREMIA - 1 PATIENT [HYBRID ESD], PERFORATION - 4 PATIENTS, BLEEDING - 4 PATIENTS, BACTEREMIA - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6); (KD-10Q-1) (B)(6); (KD-650L: SINGLE USE ELECTROSURGICAL KNIFE) (B)(6); (SD-210L-10: SNARE MASTER) (B)(6); (FD-210U: HOT BIOPSY) THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6); THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE MALFUNCTION NOR THE ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653066 DISPOSABLE ELECTROSURGICAL SNARE DISPOSABLE ELECTROSURGICAL SNARE FDI AOMORI OLYMPUS CO., LTD. SD-210L-10 UNKNOWN(LITERATURE) 04953170298462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention