BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 15257094 · Received August 19, 2022

    Report

    Report Number
    9614641-2022-00153
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    May 15, 2022
    Report Date
    September 20, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCL
    UDI-DI
    04953170031120
    PMA / PMN Number
    CLASS1-EXMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "BIOPSY FORCEPS", "FB-230U" WAS SELECTED AS A REPRESENTATIVE PRODUCT WITH THE LARGEST NUMBER OF SHIPMENTS IN THE REGION AND DURING THE STUDY PERIOD. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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 INFORMATION ADDED TO G2. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ACUTE APPENDICITIS AFTER COLORECTAL ENDOSCOPIC MUCOSAL RESECTION: A CASE REPORT". THE CASE REPORT STATED THAT A 62-YEAR-OLD MALE PATIENT WAS ADMITTED, WHO HAD A HISTORY OF MULTIPLE COLONIC POLYPS. THE LARGEST POLYP WAS TREATED BY EMR. THIS WAS FOLLOWED BY THE INJECT AND CUT TECHNIQUE. THE REMAINING FOUR POLYPS WERE REMOVED WITH BIOPSY FORCEPS. THE PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN IN THE EVENING 30 HOURS AFTER COLORECTAL EMR. THE FIRST EMERGENCY COMPUTED TOMOGRAPHY (CT) SCAN WAS SCHEDULED, AND THE RESULTS SHOWED THAT THE APPENDIX WAS SLIGHTLY THICKENED. PATHOLOGICAL ANALYSIS OF THE RESECTED APPENDIX CONFIRMED ACUTE APPENDICITIS. THIS STUDY CONCLUDED THAT FOR PATIENTS WITH PRIOR KNOWN FECALITHS IN THE LUMEN OF THE APPENDIX OR IN THE COLON NEAR THE APPENDIX, THE RISK OF ACUTE APPENDICITIS AFTER EMR COULD BE INCREASED. THUS, COLORECTAL EMR SHOULD BE PERFORMED WITH GREATER CAUTION, AND CAUTIOUS OBSERVATION SHOULD BE PERFORMED AFTER THE OPERATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ABDOMINAL PAIN CAUSED BY ACUTE APPENDICITIS - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): CF-H290I. (B)(6): FB-230U. (B)(6): CV-290. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). 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
    2576550 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS FCL AOMORI OLYMPUS CO., LTD. FB-230U UNKNOWN(LITERATURE) 04953170031120

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| O CF-H290I, SN UNKNOWN| COOK POLYPECTOMY SNARE, SN UNKNOWN| CV-290, SN UNKNOWN