BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 18889724 · Received March 12, 2024

    Report

    Report Number
    9614641-2024-00644
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    January 27, 2024
    Report Date
    March 21, 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

    THE LITERATURE DESCRIBED "IT KNIFE 2"; THEREFORE, "KD-611L" WAS SELECTED AS REPRESENTATIVE DEVICES. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE AUTHOR WAS NOT REACHABLE TO OBTAIN ANY FURTHER INFORMATION. THE INVESTIGATION IS ONGOING, AND THIS REPORT WILL BE SUPPLEMENTED WHEN NEW AND RELEVANT INFORMATION BECOMES AVAILABLE LATER.

    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, A 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. 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 "A STUDY OF INGENUITY OF ESD FOR EARLY GASTRIC CANCER IN S-8 AOSAGISATSU REGION". BACKGROUND AND OBJECTIVES THE U REGION IS CONSIDERED A DIFFICULT SITE FOR ESD IN EARLY-STAGE GASTRIC CANCER. THE DIFFICULTY OF ESD IS PARTICULARLY HIGH IN THE NODAL REGION. THE REASONS FOR THIS INCLUDE EASY SUBMERSION, THIN GASTRIC WALL, DIFFICULTY IN PROXIMITY, AND LESIONS FACING EACH OTHER. ON THE OTHER HAND, ESD HAS BECOME POSSIBLE EVEN IN THE MANDIBULAR REGION WITH THE USE OF TRACTION DEVICES AND A WIDE VARIETY OF KNIVES AND SCOPES IN RECENT YEARS. WE WILL REVIEW THE RESULTS OF ESD IN OUR CLINIC AND EXPLORE EFFECTIVE ESD TECHNIQUES. METHODS WE RETROSPECTIVELY REVIEWED THE RESULTS OF ESD AND DETAILS OF THE TECHNIQUE IN (B)(4) CASES OF EARLY GASTRIC CANCER LOCATED IN THE NUCHAL REGION OUT OF (B)(4) CASES AND (B)(4) LESIONS OF EARLY GASTRIC CANCER ESD PERFORMED AT OUR HOSPITAL FROM (B)(6) 2004 TO (B)(6) 2023. THE GIF-Q260J AND GIF-H290T SCOPES WERE DEFINED AS STANDARD SCOPES, AND THE OTHER SCOPES WERE DEFINED AS SPECIAL SCOPES. RESULTS: MEDIAN AGE 66 YEARS, GENDER (MALE/FEMALE) 16/8, GROSS TYPE: 0-ILA 8 CASES, 0-ILB 8 CASES, 0-ILC 8 CASES, H.PYLORI: NEGATIVE 15 CASES, POSITIVE 9 CASES, SITE: ANTERIOR WALL 1 CASE, POSTERIOR WALL 5 CASES, LARGE CROSSBOW 10 CASES, APICAL 8 CASES, POSTOPERATIVE RECONSTRUCTED STOMACH 2 CASES. MEDIAN RESECTION LESION DIAMETER WAS 14 MM, MEDIAN RESECTION SPECIMEN DIAMETER WAS 36 MM, DEPTH (M/SM1/SM2) WAS 14/5/5, UL WAS 1 CASE, AND POSITIVE VASCULAR INVASION WAS 1 CASE. THE MEDIAN TREATMENT TIME WAS 141 MINUTES, AND ALL PATIENTS UNDERWENT COMPLETE EN BLOC RESECTION. NO POSTERIOR HEMORRHAGE OR DELAYED PERFORATION WAS OBSERVED. INTRAOPERATIVE PERFORATION WAS OBSERVED IN 4 PATIENTS (17%), BUT IT COULD BE TREATED CONSERVATIVELY. DETAILS OF THE PROCEDURE: ALL PATIENTS RECEIVED CO2 INSUFFLATION, 3 HIGH-FREQUENCY KNIVES (FLASH KNIFE BT 1.5MM OR 2.OMM, IT KNIFE 2, AND CLUTCH CUTTER), TRACTION METHOD IN 6 CASES WITHOUT AND 18 CASES WITH, SPECIAL SCOPE IN 7 CASES (B)(6) AND (B)(6). IN THE PERFORATION CASES, NONE OF THE 4 CASES USED THE SPECIAL SCOPE, AND 3 CASES WERE LOCATED AT THE APEX, AND THE TECHNIQUE WAS PERFORMED IN THE FIELD OF VIEW WITH THE KNIFE FACING THE MUSCLE LAYER. PERFORATION IN CASES USING THE SPECIAL SCOPE WAS (B)(6), WHEREAS PERFORATION WITH THE NORMAL SCOPE WAS (B)(6) (P=(B)(6)). THE USE OF THE SPECIAL SCOPE WAS CONSIDERED TO BE A FACTOR IN AVOIDING PERFORATION BECAUSE IT PROVIDED A FIELD OF VIEW PARALLEL TO THE MUSCLE LAYER. CONCLUSION ALTHOUGH THE RATE OF ESD PERFORATION IN THE NODAL REGION IS AS HIGH AS (B)(6) AND THE CHOICE OF TREATMENT METHOD REQUIRES MORE CAREFUL CONSIDERATION, THE USE OF A SPECIAL SCOPE MAY REDUCE THE RISK OF ESD PERFORATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE PERFORATION (N=(B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910928 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-611L 04953170225963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GIF-H290T| GIF-Q260J