BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 8954833 · Received September 3, 2019

    Report

    Report Number
    8010047-2019-03165
    Event Type
    Injury
    Date Received
    September 3, 2019
    Report Date
    September 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170208409
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). SINCE THE LOT NO. IS UNKNOWN, THE MANUFACTURING HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES WHICH PASSED THE INSPECTION. FROM THE REPORTED INFORMATION, WE PRESUME THAT THE REPORTED ACCIDENTAL SYMPTOM WAS NOT DUE TO THE MALFUNCTION OF THE DEVICE, BUT OCCURRED AS A GENERAL ACCIDENTAL SYMPTOM OF THE PROCEDURE.

    Description of Event or Problem · 1

    ON AUGUST 7TH, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿VALUE OF ENDOSCOPIC ULTRASONOGRAPHY IN DIAGNOSIS OF GASTRIC STROMAL TUMOR AND THE APPLICATION OF ENDOSCOPIC SUBMUCOSAL EXCAVATION IN THE TREATMENT OF GASTRIC STROMAL TUMOR¿. THE LITERATURE REPORTED THAT 29 PROCEDURES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WERE PERFORMED USING OLYMPUS SINGLE USE ELECTROSURGICAL KNIFE (KD-620LR OR KD-611L) BETWEEN DECEMBER 2012 AND OCTOBER 2013. THE LITERATURE REPORTED THAT SYMPTOMS OCCURRED AS FOLLOWS; MILD BLEEDING: 29 CASES. THEY WERE MANAGED BY ARGON PLASMA COAGULATION OR HOT BIOPSY. IN ONE CASE SMALL ARTERY EJECTION BLEEDING OCCURRED AND HEMOSTATIC CLIP WAS USED TO CLOSE THE BLEEDING. PERFORATION: 3 CASES. THE USERS WERE SEALED BY TITANIUM CLIP AND/OR NYLON RING. ALL PATIENTS RECEIVED DIET CONTROL, GASTROINTESTINAL DECOMPRESSION, ANTI-INFECTION AND OTHER TREATMENTS. CONSERVATIVE MEDICAL TREATMENT WAS SUCCESSFUL. OMSC TRIED TO OBTAIN FURTHER INFORMATION SUCH AS THE RELATIONSHIP BETWEEN OLYMPUS DEVICE AND ALL OF THE REPORTED SYMPTOMS, BUT IT IS NOT OBTAINED FROM THE AUTHOR OF THIS LITERATURE AT PRESENT. THEREFORE, ACCORDING TO THE NUMBER OF THE TYPE OF SYMPTOMS KNOWN AND THE NUMBER OF OLYMPUS DEVICE USED FOR PROCEDURE, OMSC IS SUBMITTING 4 MEDICAL DEVICE REPORTS. THIS IS A REPORT ON PERFORATION ASSOCIATED WITH KD-620LR, AND 2 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748671 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-620LR 04953170208409

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R