BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    MDR report key: 18868702 · Received March 8, 2024

    Report

    Report Number
    9614641-2024-00627
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 14, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170405631
    PMA / PMN Number
    K171158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, THIS REPORT WILL BE SUPPLEMENTED WHEN NEW AND RELEVANT INFORMATION BECOMES AVAILABLE.

    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 RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR. B5 UPDATED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "V3-1 UTILITY AND SAFETY OF TECH KNIFE IN COLORECTAL ESD." LITERATURE SUMMARY ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF COLORECTAL TUMORS IS CONSIDERED A TECHNICALLY DIFFICULT AND TIME-CONSUMING PROCEDURE. IT HAS BEEN REPORTED THAT ADVANCES IN DEVICES CONTRIBUTE TO A REDUCTION IN THE COMPLICATION RATE, AND VARIOUS DEVICES HAVE BEEN DEVELOPED TO DATE TO IMPROVE THE SAFETY AND EFFICIENCY OF THE PROCEDURE. UNLIKE CONVENTIONAL TIP-BASED KNIVES, THE TECKNIFE (MICROTEC, INC.) CAN DELIVER FLUID FROM THE TIP OF THE KNIFE, ENABLING EFFICIENT INCISION AND DISSECTION, WHICH MAY RESULT IN A REDUCTION IN ESD PROCEDURE TIME. OBJECTIVE TO PROSPECTIVELY EVALUATE THE EFFICACY AND SAFETY OF THE MICROTEC KNIFE IN COLORECTAL ESD. METHODS (B)(4) COLORECTAL ESD CASES PERFORMED DURING A 6-MONTH PERIOD FROM (B)(6) 2023 WERE DIVIDED INTO 2 GROUPS: TK GROUP ((B)(4) CASES) USING A TECHKNIFE AND DK GROUP ((B)(4) CASES) USING DUALKNIFE J (OLYMPUS), AND COMPARED. THE PRIMARY ENDPOINT WAS DISSECTION SPEED, AND SECONDARY ENDPOINTS WERE ESD PROCEDURE TIME, THE NUMBER OF TIMES THE LOCAL INJECTION NEEDLE WAS INSERTED AND REMOVED, TOTAL LOCAL INJECTION VOLUME, AND INTRAOPERATIVE PERFORATION RATE. THE AUTHORS ALSO PERFORMED A SUBGROUP ANALYSIS BY DIVIDING THE PATIENTS INTO TWO GROUPS: EXPERTS WITH MORE THAN (B)(4) ESD CASES AND NON-EXPERTS WITH LESS THAN (B)(4) ESD CASES. RESULTS THERE WERE NO SIGNIFICANT DIFFERENCES IN PATIENT BACKGROUND (AGE, GENDER, COMORBIDITIES, ANTICOAGULANT MEDICATIONS, LOCALIZATION, GROSS TYPE, EXPERT / NOM-EXPERT) BETWEEN THE TWO GROUPS. CLINICOPATHOLOGICALLY, THE TWO GROUPS DID NOT DIFFER IN RESECTION SPECIMEN DIAMETER (36.5 MM VS 33.6 MM; P=0.22), TUMOR DIAMETER (30.8 MM VS 27.7 MM; P=0.18), PATHOLOGIC FINDINGS (ADENOMA/SERRATED LESION/CANCER 36/15/18 VS 27/16/25; P=0.31), AND RO RESECTION RATE (97.1% VS 94.1%; P=0.12). ALTHOUGH THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS IN TERMS OF TOTAL LOCALIZED VOLUME (34.3 ML VS. 32.7 MM; P=0.67), THE NUMBER OF DEVICE INSERTIONS AND REMOVALS WAS SIGNIFICANTLY LOWER IN THE TK GROUP THAN IN THE DK GROUP (2 VS. 3.5 TIMES: P<0.05), RESULTING IN A TREND TOWARD FASTER PROCEDURE TIMES IN THE TK GROUP (42.7 MIN VS 52.5 MIN; P=0.13) AND SIGNIFICANTLY FASTER DISSECTION SPEED (36.2 MM2 VS 23.4 MM2: P<0.05). DEVICE OCCLUSION WAS OBSERVED IN 3 PATIENTS (43%) IN THE TK GROUP, BUT NOT IN THE DK GROUP. INTRAOPERATIVE PERFORATION OCCURRED IN 2 PATIENTS (2.9%) IN THE DK GROUP, BUT NOT SIGNIFICANTLY (P=051). THE RESULTS OF THE EXPERT/NON-EXPERT GROUP WERE ALSO COMPARED WITH THOSE OF THE TK AND DK GROUPS, RESPECTIVELY. EXPERTS IN THE TK GROUP HAD SIGNIFICANTLY FEWER DEVICE INSERTIONS AND REMOVALS (2 VS. 3.6 TIMES; P<0.05), SHORTER ESD PROCEDURE TIMES (37.5 MIN VS 50.3 MIN; P=0.07), AND SIGNIFICANTLY FASTER DISSECTION SPEEDS (36.8 MM2 VS 26.5 MM2; P<0.05). ON THE OTHER HAND, THERE WAS NO DIFFERENCE IN ANY OF THE PARAMETERS BETWEEN THE TK AND DK GROUPS IN THE NON-EXPERT GROUP. CONCLUSION COMPARED TO THE DUALKNIFE J, THE TECHKNIFE MAY REDUCE PROCEDURE TIME BY REDUCING THE NUMBER OF TIMES THE DEVICE IS INSERTED AND REMOVED, AND BY PERFORMING DISSECTION MORE EFFICIENTLY, SUGGESTING THAT THE USE OF THE TECHKNIFE MAY BE MORE EFFECTIVE, ESPECIALLY FOR EXPERTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS INTRAOPERATIVE PERFORATION (N=2).

    Description of Event or Problem · 0

    AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195433 SINGLE USE ELECTROSURGICAL KNIFE KD-655 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-655Q 04953170405631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other