BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 12030600 · Received June 21, 2021

    Report

    Report Number
    8010047-2021-07747
    Event Type
    Injury
    Date Received
    June 21, 2021
    Report Date
    June 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "SALVAGE ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LOCAL RESIDUAL / RECURRENT COLORECTAL TUMOR AFTER ENDOSCOPIC RESECTION:LARGE MULTICENTER 10-YEAR STUDY". THE PURPOSE OF THE LITERATURE WAS TO DETERMINE THE SAFETY AND EFFICACY OF COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR LOCAL RESIDUAL/RECURRENT TUMORS INCLUDING ENDOSCOPIC RESECTION (ER) INTERRUPTED TUMORS FROM A LARGE MULTICENTER STUDY. THE ESD WAS PERFORMED USING A KNIFE (OLYMPUS; DUAL KNIFE, ITKNIFE NANO, OR NON-OLYMPUS), A STANDARD TIP HOOD (OLYMPUS OR NON-OLYMPUS), AND SODIUM HYALURONATE (NON-OLYMPUS). FROM (B)(6) 2008 UNTIL (B)(6) 2018, 3,937 COLORECTAL TUMORS WERE RESECTED BY ESD AT THE HIROSHIMA GI ENDOSCOPY RESEARCH GROUP. FROM THIS GROUP, 81 LOCAL RESIDUAL/ RECURRENT TUMORS AND 21 ER INTERRUPTED TUMORS WERE INCLUDED. IN THE LITERATURE, ONE INTRAOPERATIVE PERFORATION REQUIRED FURTHER SURGERY WAS REPORTED. IN ADDITION, FOUR INTRAOPERATIVE PERFORATIONS AND ONE DELAYED PERFORATION HEALED BY USING ENDOSCOPIC CLIP, ONE DELAYED PERFORATION REQUIRED FURTHER SURGERY, AND TWO POSTOPERATIVE BLEEDINGS ACHIEVED BY ENDOSCOPIC HEMOSTASIS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, ONE INTRAOPERATIVE PERFORATION REQUIRED FURTHER SURGERY MIGHT BE SERIOUS INJURY, AND OLYMPUS KNIFE MIGHT BE USED WHEN THE PERFORATION OCCURRED. THIS IS THE REPORT REGARDING THE PATIENT WITH ONE INTRAOPERATIVE PERFORATION REQUIRED FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933110 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention