BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 18515035 · Received January 15, 2024

    Report

    Report Number
    9614641-2024-00085
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    October 23, 2023
    Report Date
    March 7, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170225963
    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 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

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. DOI.ORG/10.5230/JGC.2023.23.E37 PROVIDED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE LITERATURE TITLED: "INDICATIONS FOR DENTAL FLOSS CLIP TRACTION DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BY LESS-EXPERIENCED ENDOSCOPISTS." THIS RETROSPECTIVE STUDY INVESTIGATED THE INDICATIONS OF DENTAL FLOSS CLIP (DFC) IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED BY LESS-EXPERIENCED ENDOSCOPISTS FOR EARLY GASTRIC CANCER. A TOTAL OF 812 PATIENTS WERE INCLUDED. THE PROCEDURE TIME IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP (95±46 VS. 75±31, P<0.01). THE PROCEDURE TIME FOR LESIONS LOCATED IN THE GREATER CURVATURE OF THE UPPER OR MIDDLE STOMACH AND LESIONS >20 MM LOCATED IN THE LESSER CURVATURE SIDE OF THE STOMACH IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING - 30 PATIENTS, PERFORATION - 10 PATIENTS. DELAYED BLEEDING WAS DEFINED AS CLINICAL BLEEDING AFTER ESD THAT REQUIRED BLOOD TRANSFUSION OR ENDOSCOPIC OR SURGICAL INTERVENTION. PERFORATION WAS DIAGNOSED WHEN MESENTERIC FAT OR INTRA-ABDOMINAL SPACE WAS OBSERVED DURING THE PROCEDURE OR WHEN FREE AIR WAS IDENTIFIED ON SIMPLE CHEST AND ABDOMINAL RADIOGRAPHS AFTER ESD. RELATED PATIENT IDENTIFIERS: (B)(6). - EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE (GIF-Q260J). (B)(6). - DISPOSABLE DISTAL ATTACHMENT (D-201-11804). (B)(6). - SINGLE USE ELECTROSURGICAL KNIFE (KD-611L). (B)(6). - SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS (FD-410LR). (B)(6). - ROTATABLE CLIP FIXING DEVICE (HX-110LR). (B)(6).- CLIP (HX-610-090). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705574 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-611L UNKNOWN(LITERATURE) 04953170225963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CLIP (HX-610-090)| DISPOSABLE DISTAL ATTACHMENT (D-201-11804)| ELECTROSURGICAL HEMOSTATIC FORCEPS (FD-410LR)| GASTROINTESTINAL VIDEOSCOPE (GIF-Q260J)| ROTATABLE CLIP FIXING DEVICE (HX-110LR)