BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 13771088 · Received March 15, 2022

    Report

    Report Number
    8010047-2022-04450
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 18, 2021
    Report Date
    June 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Removal / Correction Number
    Z-1292-2021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. CORRECTION AND PREVENTATIVE ACTION (CAPA) INVESTIGATION HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    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 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE LITERATURE TITLED "INCIDENCE AND MANAGEMENT OF CYSTIC DUCT PERFORATION DURING ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE FOR ACUTE CHOLECYSTITIS" BY KAZUNARI NAKAHARA, ET AL. THIS RETROSPECTIVE SINGLE-CENTER STUDY WAS AIMED TO INVESTIGATE THE INCIDENCE OF CYSTIC DUCT PERFORATION (CDP) AS A SPECIFIC ADVERSE EVENT DURING THE ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE (ETGBD) PROCEDURE, ALSO THE MANAGEMENT AND THE CLINICAL OUTCOME OF CDP DURING ETGBD. OUT OF 249 CONSECUTIVE PATIENTS WITH ACUTE CHOLECYSTITIS (AC) INCLUDED WHO UNDERWENT ETGBD, CDP WAS OBSERVED IN 23 (9.2%) PATIENTS AND WAS CAUSED BY THE GW AND CANNULA, WITH NO PERFORATIONS BY STENTS OR CATHETERS. THE STUDY REPORTED TECHNICAL SUCCESS RATE WAS 53.5% (8/15) FOR CDP CAUSED BY GWS AND 25.0% (2/8) FOR CDP CAUSED BY CANNULAS WITH A REPORTED RATE OF TECHNICAL SUCCESS WAS 53.5% (8/15) FOR CDP CAUSED BY GWS AND 25.0% (2/8) FOR CDP CAUSED BY CANNULAS. THE STUDY ALSO CLAIMED THAT ETGBD TECHNICAL SUCCESS RATES, PROCEDURE TIMES, AND HOSPITALIZATION PERIODS WERE SIGNIFICANTLY INFERIOR IN THE CDP GROUP (N = 23) COMPARED WITH THE NON-CDP GROUP (N = 216). IN CONCLUSION, THE CDP REDUCED THE ETGBD TECHNICAL SUCCESS RATE. HOWEVER, EVEN IN PATIENTS WITH CDP, AN IMPROVEMENT OF AC WAS ACHIEVED BY SUBSEQUENT SUCCESSFUL ETGBD OR ADDITIONAL PROCEDURES. ADVERSE EVENTS: CDP GROUP: -ACUTE PANCREATITIS (MILD AND MODERATE SEVERITY IN ONE EACH); BOTH IMPROVED WITH CONSERVATIVE TREATMENT. (N=2) -CDP DURING ETGBD, CAUSED BY GUIDEWIRE (N=15): AN IMPROVEMENT OF ACUTE CHOLECYSTITIS WAS ACHIEVED BY SUBSEQUENT SUCCESSFUL ETGBD OR ADDITIONAL PROCEDURES, SUCH AS PERCUTANEOUS DRAINAGE. CDP WAS DEFINED AS THE DISLOCATION OF DEVICES, SUCH AS GW OR CANNULA, OR THE LEAKAGE OF CONTRAST MEDIA INTO THE PERITONEAL CAVITY FROM THE CYSTIC DUCT LUMEN CONFIRMED BY FLUOROSCOPIC IMAGING. NON-CPD GROUP: PANCREATITIS (11), BLEEDING (1). THIS ARTICLE INCLUDES 2 REPORTS FOR THE OLYMPUS DEVICES AND REPORTED ADVERSE EVENTS: (B)(6): JF-260V OR TJF-260V, EVIS LUCERA DUODENOVIDEOSCOPE. JF-260V WAS SELECTED AS A REPRESENTATIVE DEVICE. (B)(6): TJF-Q290V, EVIS LUCERA ELITE DUODENOVIDEOSCOPE. THIS IS REPORT 2 OF 2 FOR (B)(6): TJF-Q290V, EVIS LUCERA ELITE DUODENOVIDEOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664010 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O UNKNOWN VISIGLIDE