BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 14580293 · Received June 2, 2022

    Report

    Report Number
    8010047-2022-09312
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    March 15, 2021
    Report Date
    July 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND BASED ON THE LITERATURE, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE EXACT CAUSE OF THE PATIENT¿S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT WAS REPORTED THAT THE INTRA OPERATION BLEEDING WAS CONTROLLED BY UTILIZING A HEMOSTATIC FORCEPS, AND THERE WERE NO DELAYED COMPLICATIONS. IF NEW AND RELEVANT INFORMATION BECOMES AVAILABLE LATER, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN B3, H6, AND H10. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORPORATION RECEIVED A LITERATURE TITLED "FEASIBILITY STUDY OF PARTIAL SUBMUCOSAL INJECTION TECHNIQUE COMBINING UNDERWATER EMR FOR SUPERFICIAL DUODENAL EPITHELIAL TUMORS." LITERATURE SUMMARY: THIS PROSPECTIVE OBSERVATIONAL STUDY EXPLAINED FEASIBILITY AND SAFETY OF PARTIAL SUBMUCOSAL INJECTION COMBINING UNDER WATER ENDOSCOPIC MUCOSAL RESECTION (PI-UEMR) FOR SUPERFICIAL DUODENAL TUMOR (SDET). A TOTAL OF 30 PATIENTS WERE INVOLVED WHICH UNDERWENT PI-UEMR USING GIF-Q260J OR GIF-H290T- GASTROSCOPE, ENDOSCOPIC SNARE, ENDOSCOPIC CLIP AND MANY OTHER DEVICES. EN BLOC RESECTION RATE WAS 97%. R0 RESECTION RATE WAS 83%. MEAN TOTAL PROCEDURE TIME WAS 17±12 MIN. COMPLICATIONS LIKE INTRAOPERATIVE BLEEDING WAS OBSERVED IN ONE CASE AND DURING HISTOLOGICAL FINDINGS 29 CASES OF TUBULAR ADENOMA AND ONE CASE OF DUODENITIS WERE OBSERVED. THE STUDY CONCLUDED THAT PI-UEMR MIGHT BE VERY USEFUL AND SAFE TECHNIQUE OF ENDOSCOPIC RESECTION FOR SDET INCLUDING RELATIVELY LARGE LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE BLEEDING (1). HISTOLOGICAL FINDINGS: TUBULAR ADENOMA 29), DUODENITIS (1) . SINCE THE LITERATURE DESCRIBED "SNAREMASTER (10, 15, OR 20 MM)", WE SELECTED "SD-210L-10" AS A REPRESENTATIVE PRODUCT. THE PRODUCT WAS UNKNOWN, BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. SINCE THE LITERATURE DESCRIBED "EZ CLIP", WE SELECTED "HX-110LR" AS A REPRESENTATIVE PRODUCT. THE PRODUCT WAS UNKNOWN, BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. FOUR REPORTS WERE CREATED BASED ON THIS LITERATURE TO SPECIFICALLY ACCOUNT FOR THOSE OLYMPUS DEVICES USED IN THIS STUDY AND THEY ARE AS FOLLOWS: (B)(6) WHICH IS FOR THE DISPOSABLE ELECTROSURGICAL SNARE . (B)(6) WHICH IS FOR HX-110LR. (B)(6) WHICH IS FOR GIF-Q260J. (B)(6), WHICH IS FOR GIF-H290T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586681 DISPOSABLE ELECTROSURGICAL SNARE DISPOSABLE ELECTROSURGICAL SNARE FDI OLYMPUS MEDICAL SYSTEMS CORP. SD-210L-10 UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GIF-H290T, SERIAL NUMBER UNKNOWN.| GIF-Q260J, SERIAL NUMBER UNKNOWN.| HX-110LR, LOT NUMBER UNKNOWN.