BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-612

    MDR report key: 20505391 · Received October 22, 2024

    Report

    Report Number
    9614641-2024-02010
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 20, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 REPORTED EVENT WAS LIKELY, AN ACCIDENT OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE, WHILE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - CLINICAL CODE- DETERIORATION OF CHRON'S DISEASE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THERE WAS NO DEVICE MALFUNCTION, DURING ANY OF THE PROCEDURES. DESCRIBED IN THE ARTICLE. ALSO, AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ADVERSE EVENTS.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "SAFETY AND EFFECTIVENESS OF ADDITIONAL TRIAMCINOLONE ACETONIDE WITH ENDOSCOPIC RADIAL INCISION AND CUTTING FOR BENIGN STENOSIS OF THE LOWER GASTROINTESTINAL TRACT: A PILOT STUDY." LITERATURE SUMMARY OBJECTIVES: RADIAL INCISION AND CUTTING (RIC) IS BEING INVESTIGATED AS AN ALTERNATIVE ENDOSCOPIC DILATION METHOD FOR LOWER INTESTINAL TRACT STENOSIS, PROVIDING A HIGH TECHNICAL SUCCESS RATE AND IMPROVING SUBJECTIVE SYMPTOMS. HOWEVER, SEVERAL PATIENTS DEVELOP RE-STENOSIS FOLLOWING RIC. IN THIS PILOT STUDY, WE AIMED TO EVALUATE THE SAFETY AND EFFICACY OF TRIAMCINOLONE ACETONIDE (TA) ADDITION AFTER RIC. OBJECTIVES: RADIAL INCISION AND CUTTING (RIC) IS BEING INVESTIGATED AS AN ALTERNATIVE ENDOSCOPIC DILATION METHOD FOR LOWER INTESTINAL TRACT STENOSIS, PROVIDING A HIGH TECHNICAL SUCCESS RATE AND IMPROVING SUBJECTIVE SYMPTOMS. HOWEVER, SEVERAL PATIENTS DEVELOP RE-STENOSIS FOLLOWING RIC. IN THIS PILOT STUDY, WE AIMED TO EVALUATE THE SAFETY AND EFFICACY OF TRIAMCINOLONE ACETONIDE (TA) ADDITION AFTER RIC. METHODS: RIC WITH TA WAS PERFORMED IN (B)(4) PATIENTS WITH LOWER GASTROINTESTINAL TRACT STENOSIS. WE EVALUATED THE RATE OF ADVERSE EVENTS 2 MONTHS AFTER RIC WITH TA. WE INVESTIGATED THE SHORT- AND LONG-TERM PROGNOSES, AS WELL AS THE IMPROVEMENT IN SUBJECTIVE SYMPTOMS, USING A VISUAL ANALOG SCALE. RESULTS: THE DELAYED BLEEDING RATE AFTER RIC WAS (B)(4). ENDOSCOPIC HEMOSTASIS WAS ACHIEVED IN ALL PATIENTS WITH DELAYED BLEEDING. NO PERFORATIONS WERE OBSERVED. THE CUMULATIVE RE-STENOSIS-FREE, RE-INTERVENTION-FREE, AND SURGERY-FREE RATES 1 YEAR AFTER RIC WERE (B)(4), RESPECTIVELY. SUBJECTIVE SYMPTOMS, INCLUDING ABDOMINAL PAIN, ABDOMINAL BLOATING, NAUSEA, AND DYSCHEZIA, SIGNIFICANTLY IMPROVED AFTER RIC WITH TA. CONCLUSION: ALTHOUGH ADDITIONAL TA ADMINISTRATION AFTER RIC COULD BE SAFE, ADDITIONAL TA MAY NOT BE EFFECTIVE ON LUMINAL PATENCY AFTER DILATION. FURTHER INVESTIGATION IS WARRANTED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS DELAYED BLEEDING (B)(4). DETERIORATION OF CDS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005420 SINGLE USE ELECTROSURGICAL KNIFE KD-612 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-612Q

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention COLONOVIDEOSCOPE, PCF-H290TI, SN-UNK