BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 7968107 · Received October 15, 2018

    Report

    Report Number
    8010047-2018-01987
    Event Type
    Injury
    Date Received
    October 15, 2018
    Report Date
    October 16, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THE EVENTS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿CURRENT STATUS OF ENDOSCOPIC RESECTION FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS (SNADETS)¿. THE LITERATURE REPORTED THE RESULT OF ER (ENDOSCOPIC RESECTION) PROCEDURES FOR 158 PATIENTS AT THE USER FACILITY BETWEEN JANUARY 2006 AND DECEMBER 2016. THE LITERATURE REPORTED THAT OLYMPUS GASTROINTESTINALVIDEOSCOPE (GIF-Q260J) AND COLONOVIDEOSCOPE (PCF-Q260JI) WERE USED IN THE PROCEDURES. IN THE LITERATURE, THE EFFECTS OF FIVE METHOD (CSP: COLD SNARE POLYPECTOMY, EMR: ENDOSCOPIC MUCOSAL RESECTION, UEMR: UNDERWATER ENDOSCOPIC MUCOSAL RESECTION, ESD: ENDOSCOPIC SUBMUCOSAL DISSECTION, LECS: LAPAROSCOPIC-ENDOSCOPE COOPERATIVE SURGERY) IN ER PROCEDURE ARE EVALUATED. IN THE SUBJECT PROCEDURES, DELAYED BLEEDING IN 8 PATIENTS, DELAYED PERFORATION IN 4 PATIENTS AND INTRAOPERATIVE PERFORATION OCCURRED. THE LITERATURE REPORTED ¿ER METHODS FOR TREATING SNADETS WERE PROPOSED BASED ON THE LESION SIZE. FOR LARGE LESIONS, PROPHYLACTIC METHODS FOR ADVERSE EVENTS SHOULD BE IMPLEMENTED.¿ THERE WAS NO INFORMATION ON WHICH MODEL OF THE ENDOSCOPE WAS USED IN EACH PROCEDURE. FURTHER DETAILED INFORMATION COULD NOT BEEN OBTAINED AT PRESENT. THEREFORE, ACCORDING TO THE NUMBER OF THE TYPE OF COMPLICATION (DELAYED BLEEDING, DELAYED PERFORATION AND INTRAOPERATIVE PERFORATION), OMSC IS SUBMITTING 3 MEDICAL DEVICE REPORTS FOR EACH ENDOSCOPE MODEL (TOTAL 6 OF MDRS). THIS IS A REPORT ON DELAYED PERFORATION IN PCF-Q260JI AND 5 OF 6 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804941 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-Q260JI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other