BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 16625178 · Received March 27, 2023

    Report

    Report Number
    9614641-2023-00438
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    August 7, 2022
    Report Date
    May 3, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170225963
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED EVENT. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5.

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "IT KNIFE 2", WE SELECTED "KD-611L" AS A REPRESENTATIVE PRODUCT. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    THE AUTHOR FURTHER CLARIFIED THAT THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICE, NOR DID IT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED. THE FACILITY DISPOSED OF THE DEVICES AFTER USING, SO NO LOT/SERIAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF ONE-STEP KNIFE COMPARED TO CONVENTIONAL INSULATED-TIP KNIFE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION: A PRELIMINARY STUDY WITH PROSPECTIVE DATA COLLECTION AND RETROSPECTIVE REVIEW". THIS PROSPECTIVE DATA COLLECTION AND RETROSPECTIVE REVIEW, AIMED TO COMPARE THE INSULATED TIP TYPE OF ONE STEP KNIFE (OSK) AND CONVENTIONAL KNIFE (CK) IN TERMS OF PROCEDURE TIME AND COMPLICATION RATE. A TOTAL OF 203 PATIENTS WERE INCLUDED IN THE STUDY (OSK (N = 102) & CK (N = 101). THE PROCEDURE TIME OF ESD WAS SHORTER IN OSK GROUP ALL SITUATIONS EXCEPT FOR THE RESECTION OF SUBMUCOSAL CANCER. THE PROCEDURE TIME FOR EACH LOCATION WAS MORE REDUCED IN THE BODY (MEDIAN 14 VS. 19 MIN P<0.01) THAN THE ANTRUM (MEDIAN 10 VS. 14 MIN, P=0.01) IN THE OSK GROUP. THE COMPLICATIONS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN BOTH GROUPS. IN SUMMARY, OSK IS A SAFE AND EFFECTIVE KNIFE COMPARED TO CONVENTIONAL KNIVES AND SHOWED FASTER PROCEDURE TIME, ESPECIALLY IN GASTRIC BODY LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BLEEDING - 8 PATIENTS; PERFORATION - 3 PATIENTS; ALL COMPLICATIONS WERE CONTROLLED BY ENDOSCOPIC MANAGEMENT. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) (FOR KD-611L); (B)(6) (FOR GIF-HQ290). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427746 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-611L 04953170225963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R EVIS LUCERA ELITE GI VIDEOSCOPE ¿ SERIAL UNKNOWN.