BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Single Use Electrosurgical Knife KD-650

    MDR report key: 12873402 · Received November 25, 2021

    Report

    Report Number
    2951238-2021-00441
    Event Type
    Injury
    Date Received
    November 25, 2021
    Report Date
    November 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170265785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "INSULATED-TIP KNIFE TUNNELING AND C-SHAPED INCISION FOR ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION: AN INITIAL WESTERN EXPERIENCE¿. THE PURPOSE OF THE LITERATURE WAS TO INVESTIGATE THE FEASIBILITY AND SAFETY OF IT-KNIFE TUNNELING AND C-SHAPED INCISION ESOPHAGEAL ESD IN THE WEST. ALL ESD PROCEDURES WERE PERFORMED WITH AN OLYMPUS GIF-H190 UPPER ENDOSCOPE (OLYMPUS) FITTED WITH A DISPOSABLE STRAIGHT SOFT DISTAL ATTACHMENT (D-201-11804; OLYMPUS). IF SUBMUCOSAL FIBROSIS WAS ENCOUNTERED, ESD TECHNIQUE WOULD BE CONVERTED TO DUALKNIFE (KD-650U; OLYMPUS) DISSECTION FOR THE FIBROTIC AREAS. A DUALKNIFE WAS USED FOR MAKING CAUTERY MARKINGS AROUND THE LESION AND AN IT-KNIFE NANO (KD-610L; OLYMPUS) WAS USED FOR SUBMUCOSAL DISSECTION. BLOOD VESSEL COAGULATION WAS PERFORMED WITH A COAGRASPER HEMOSTATIC FORCEPS (FD-410LR; OLYMPUS). AN ELECTROSURGICAL GENERATOR AND AN INJECTION NEEDLE WERE USED, BUT THE DEVICES WERE NON-OLYMPUS DEVICES. IN THE LITERATURE, IT WAS REPORTED ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS AND ONE CASE OF A DELAYED BLEEDING REQUIRING EMERGENCY ENDOSCOPY. THERE IS NO MORE INFORMATION ABOUT ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS. THE LITERATURE WROTE, ¿THERE WAS ONE CASE WITH DELAYED BLEEDING REQUIRING EMERGENCY ENDOSCOPY. THIS PATIENT WAS A CIRRHOTIC WHO DID NOT REQUIRE A BLOOD TRANSFUSION BUT REPEAT ENDOSCOPY NOTED A BLEEDING SUBMUCOSAL VESSEL THAT WAS COAGULATED.¿ BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS AND ONE CASE OF A DELAYED BLEEDING REQUIRING EMERGENCY ENDOSCOPY MIGHT BE SERIOUS INJURY, AND THE OLYMPUS KNIFE MIGHT BE USED WHEN THE CASES OCCURRED. THIS IS THE REPORT REGARDING ONE CASE OF AN INTRAPROCEDURAL BLEEDING REQUIRING ONE UNIT OF PACKED RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773597 Single Use Electrosurgical Knife KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-650U 04953170265785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other