BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

    MDR report key: 17168101 · Received June 20, 2023

    Report

    Report Number
    9614641-2023-00876
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    October 13, 2022
    Report Date
    July 5, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170208430
    PMA / PMN Number
    K062517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE WAS REPORTED AS THE PUBLICATION DATE OF THE LITERATURE. THE FOLLOWING PROCEDURE AND DEVICES ARE USED IN THIS LITERATURE. DUAL KNIFE J : WE ASSUMED THAT THIS MODEL IS KD-655Q. ESD KNIFE OR HEMOSTATIC FORCEPS (COAGRASPER FD- 410 LR) . LITERATURE ARTICLE IS ATTACHED FOR REFERENCE. THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL 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 A CORRECTION TO G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. 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, "HIGH PROFICIENCY OF ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITH A "TUNNEL + CLIP TRACTION" STRATEGY: A LARGE FRENCH MULTICENTRIC STUDY." LITERATURE SUMMARY THIS STUDY AIMED TO ASSESS THE TECHNICAL RESULTS AND OUTCOMES OF A "TUNNEL+CLIP" STRATEGY FOR ESOPHAGEAL ESD PROCEDURES PERFORMED BY LESS EXPERIENCED OPERATORS FOR THE TREATMENT OF SUPERFICIAL NEOPLASMS. A TOTAL 195 ESOPHAGEAL ESD PROCEDURES PERFORMED. THE PERCENTAGE OF RESECTED ESOPHAGEAL CIRCUMFERENCE IN SUPERFICIAL SQUAMOUS CELL CARCINOMAS (SSC) TENDED TO BE HIGHER THAN THAT IN HIGH-GRADE DYSPLASIA (HGD)/ADENOCARCINOMA (ADK) COMPLICATING BARRETT¿S ESOPHAGUS (BE). THE EN BLOC, R0 AND CURATIVE RESECTION RATES WERE BOTH HIGHER IN HGD/ADK COMPLICATING BE THAN IN SSCS. NO SIGNIFICANT DIFFERENCE WAS FOUND IN TERMS OF R0 RESECTION, RATE OF PERFORMING THE PROCEDURE, OR PERFORATION ACCORDING TO THE LOCATION OF THE LESION (UPPER THIRD, MIDDLE THIRD, LOWER THIRD, ESOPHAGOGASTRIC JUNCTION). THE ¿TUNNEL+CLIP¿ STRATEGY IS SAFE, AND ALLOWS TO ACHIEVE HIGH EN BLOC, R0 AND CURATIVE RESECTION RATES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: PERFORATION - 1 PATIENT ( TREATED ENDOSCOPICALLY WITH 4 CLIPS AND INTRAVENOUS ANTIBIOTICS. EVENT2: POSTPROCEDURAL BLEEDING - 7 PATIENTS (MANAGED ENDOSCOPICALLY) POSTPROCEDURAL BLEEDING WAS RECORDED IF IT TRIGGERED AN EMERGENCY CONSULTATION OR HOSPITALIZATION. EVENT3: STENOSIS - 31 PATIENTS (MANAGED BY ENDOSCOPIC HYDRAULIC DILATION. PATIENT IDENTIFIERS: (B)(6)- DUAL KNIFE USED IN THE PROCEDURE. (B)(6)- HEMOSTATIC FORCEPS USED IN THE PROCEDURE. THIS REPORT IS FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206264 SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS KNS AOMORI OLYMPUS CO., LTD. FD-410LR UNKNOWN(LITERATURE) 04953170208430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention