BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 19840348 · Received July 26, 2024

    Report

    Report Number
    9614641-2024-01520
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    February 15, 2024
    Report Date
    September 11, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170208409
    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 AND CORRECTION TO D4 (UDI). THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: ADVERSE EVENT 1 (B)(6). ADVERSE EVENT 2 (B)(6). ADVERSE EVENT 3 (B)(6). THIS MDR IS FOR ADVERSE EVENT 2. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS: A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN THE CC-EFTR GROUP PROGRESSED TO LOCALIZED PERITONITIS, HOWEVER, THEY RECOVERED AFTER CONSERVATIVE CARE, INCLUDING BROAD-SPECTRUM ANTIBIOTIC ADMINISTRATION (2.0% FOR ESD VS. 6.3% FOR CC-EFTR, P=0.311). TWO PATIENTS UNDERWENT EMERGENT OPERATIONS DURING THE EMERGENCY ROOM. IN THE ESD GROUP, A PATIENT WITH SEVERE BLEEDING DURING THE PROCEDURE UNDERWENT EMERGENT WEDGE RESECTION. IN THE CC-EFTR GROUP, A PATIENT WITH FAILED ENDOSCOPIC CLOSURE FOR A HUGE TRANSMURAL HOLE DURING ER UNDERWENT EMERGENT WEDGE RESECTION. ALL OTHER PATIENTS WERE MANAGED WITH CONSERVATIVE TREATMENT, INCLUDING ENDOSCOPIC CLOSURE WITH HEMOSTATIC CLIPS AND INTRAVENOUS ANTIBIOTICS, WITHOUT ANY FURTHER ADVERSE EVENTS. RESULTS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND CC-EFTR WERE PERFORMED IN 51 AND 32 PATIENTS, RESPECTIVELY. THE GISTS WERE DETECTED IN THE UPPER THIRD OF THE STOMACH FOR ESD (52.9%) AND CC-EFTR (90.6%). WITHIN THE CC-EFTR GROUP, A MAJORITY OF GISTS WERE LOCATED IN THE DEEP MUSCULARIS PROPRIA OR SEROSAL LAYER, ACCOUNTING FOR 96.9%, AS OPPOSED TO THOSE IN THE ESD GROUP (45.1%). THE R0 RESECTION RATES WERE 51.0% AND 84.4% IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. SEVEN (8.4%) PATIENTS REQUIRED SURGICAL TREATMENT (SIX PATIENTS UNDERWENT ESD AND ONE UNDERWENT CC-EFTR,) DUE TO RESIDUAL TUMOR (N=5) AND POST-PROCEDURE ADVERSE EVENTS (N=2). PATIENTS UNDERGOING R0 OR R1 RESECTION DID NOT EXPERIENCE RECURRENCE DURING A MEDIAN 14-MONTH FOLLOW-UP PERIOD, EXCEPT FOR ONE PATIENT IN THE ESD GROUP. CONCLUSIONS: CC-EFTR DISPLAYED A HIGH R0 RESECTION RATE; THEREFORE, IT IS A SAFE AND EFFECTIVE THERAPEUTIC OPTION FOR SMALL GASTRIC GISTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS ADVERSE EVENT 1 (BLEEDING - FEMALE, 63). ADVERSE EVENT 2 (PERFORATION - MALE, 72). ADVERSE EVENT 3 (FEVER -20 PATIENTS, PNEUMOPERITONEUM -35 PATIENTS, PERITONITIS -3 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776116 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-620LR 04953170208409

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention