BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    MDR report key: 20844220 · Received December 4, 2024

    Report

    Report Number
    9614641-2024-02130
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    August 5, 2024
    Report Date
    February 20, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170377532
    PMA / PMN Number
    K171158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - CLINICAL CODE-STRICTURE FORMATION AT ESD SITE. THE LITERATURE DESCRIBED ¿DUAL KNIFE/DUAL KNIFE J (KD 650L/KD 665U)¿, BUT SINCE THERE IS NO DEVICE NAMED ¿KD 665U¿, IT IS THOUGHT TO BE A TYPO FOR ¿KD-655U¿. THEREFORE, A COMPLAINT WAS INITIATED FOR ¿KD-655U¿. 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.

    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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL AUDIT OF ENDOSCOPIC SUB-MUCOSAL DISSECTION PERFORMED FOR COMPLEX LATERAL SPREADING COLORECTAL TUMORS FROM A REGION NON-ENDEMIC FOR COLORECTAL CANCER." LITERATURE SUMMARY: BACKGROUND ENDOSCOPIC RESECTION IS CURRENTLY THE TREATMENT OF CHOICE FOR LATERALLY SPREADING TUMORS (LSTS). ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) CAN ACHIEVE HIGHER ENBLOC RESECTION AND R0 RESECTION, ALBEIT AT A SLIGHTLY HIGHER RISK OF COMPLICATIONS. GIVEN SCARCE DATA ON ESD FROM INDIA, WE PERFORMED A RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE WITH COLORECTAL ESD (CR-ESD) TO KNOW ITS CLINICAL EFFICACY AND COMPLICATIONS AS WELL AS TO ASSESS THE LEARNING CURVE OF CR-ESD IN NON-ENDEMIC-AREAS. METHODS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY MAINTAINED DATASHEET PERFORMED. ALL PATIENTS WITH LARGE (>2CM), COMPLEX OR RECURRENT COLORECTAL LST WHO UNDERWENT ESD AT OUR CENTER BETWEEN 2012 AND 2021 WERE INCLUDED IN THE STUDY. VARIOUS BASELINE LESION-RELATED PARAMETERS, PROCEDURE-RELATED PARAMETERS, ENBLOC RESECTION (ER) RATES, R0 MARGINS AND ADVERSE EVENT RATES WERE RETRIEVED. CUSUM ANALYSIS WAS PERFORMED TO CALCULATE THE MINIMUM REQUIRED PROCEDURES TO ACHIEVE COMPETENCY IN CR-ESD. RESULTS: TOTAL 149 PATIENTS WERE INCLUDED IN THE STUDY; MEAN PATIENT AGE WAS 61.36±18.21 YEARS. MOST PATIENTS HAD LESIONS IN RECTUM (N=102; 68.5%) FOLLOWED BY SIGMOID COLON (N=25; 16.8%). THE MEAN LESION SIZE WAS 46.62 ± 25.46 MM AND THE MEAN PROCEDURE DURATION FOR ESD WAS 219.30 ± 150.05 MIN. ER WAS ACHIEVED IN 94.6% OF LESIONS. R0 RESECTION WAS ACHIEVED IN 132 PATIENTS (88.6%). OVERALL, SIX (4%) ADVERSE EVENTS WERE NOTED, OF WHICH ONE REQUIRED SURGICAL INTERVENTION. AS MANY AS 105 PATIENTS (70.5%) HAD ADENOMATOUS LESIONS ON HISTOLOGY. SEVENTY-FOUR PATIENTS UNDERWENT FOLLOW-UP COLONOSCOPY, OF WHICH THREE HAD A RECURRENCE OF ADENOMATOUS LESIONS AND FIVE HAD POST-RESECTION STRICTURE REQUIRING ENDOSCOPIC DILATION. CUSUM CURVE ANALYSIS CALCULATED THE LEARNING CURVE FOR ESD WAS 47 RESECTIONS FOR ER AND 55 FOR THE OCCURRENCE OF AES, WITH A COMPOSITE CUSUM AT 47 PROCEDURES. CONCLUSION CR-ESD EVEN IN NON-ENDEMIC AREA IS ASSOCIATED WITH HIGH EN BLOC RESECTION RATES, R0 RESECTION RATES AND ACCEPTABLE COMPLICATION PROFILE. APPROXIMATELY 50 CASES OF CR-ESD ARE REQUIRED TO ACHIEVE COMPETENCY. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS: PERFORATION - 2 PATIENTS. INTRA-PROCEDURAL BLEEDING - 1 PATIENT. POST-PROCEDURAL FEVER - 2 PATIENTS. ABDOMINAL PAIN - 1 PATIENT. STRICTURE FORMATION AT ESD SITE - 5 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095918 SINGLE USE ELECTROSURGICAL KNIFE KD-655 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-655U 04953170377532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GASTROINTESTINAL VIDEOSCOPE, GIF-HQ190, SN-UNK| HEMOSTATIC FORCEPS, FD-411UR, SN-UNK| SINGLE USE ELECTROSURGICAL KNIFE, KD-650L, SN-UNK