BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 18460737 · Received January 5, 2024

    Report

    Report Number
    9610595-2024-00382
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    August 10, 2023
    Report Date
    January 23, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - CLINICAL CODE-: ADVERSE EVENTS REPORTED ARE CHOLEDOCHOLETHIASIS AND CHOLECYSTITIS AND HYPERAMYLASEMIA . 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.

    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 EVENTS 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.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ROLE OF BILIARY STENT IN RECURRENCE OF BILIARY STONES AND COMPLICATIONS AFTER STONE CLEARANCE IN PATIENTS AWAITING CHOLECYSTECTOMY: A RANDOMIZED TRIAL". LITERATURE SUMMARY INTRODUCTION: THE ROLE OF PROPHYLACTIC BILIARY STENTING AFTER CLEARANCE OF CHOLEDOCHOLITHIASIS IN PATIENTS AWAITING CHOLECYSTECTOMY FOR CONCOMITANT CHOLELITHIASIS IS CONTROVERSIAL. WE PLANNED A RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF PROPHYLACTIC BILIARY STENTING AFTER ACHIEVING BILIARY CLEARANCE IN REDUCING RECURRENCE OF CHOLEDOCHOLITHIASIS AND BILIARY COMPLICATIONS IN PATIENTS AWAITING CHOLECYSTECTOMY. METHODS: PATIENTS WITH CONCOMITANT CHOLELITHIASIS AND CHOLEDOCHOLITHIASIS WERE INCLUDED, AND THOSE WHO HAD EVIDENCE OF CLEARANCE OF CHOLEDOCHOLITHAISIS (DOCUMENTED ON OCCLUSION CHOLANGIOGRAM DURING ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY [ERC]) WERE RANDOMIZED TO PROPHYLACTIC BILIARY STENTING OR NO STENTING. CHOLEDOCHOLITHAISIS RECURRENCE RATE (PRIMARY OUTCOME), BILIARY COMPLICATIONS AND NEED FOR REPEAT/EMERGENCY ERC (SECONDARY OUTCOMES) WERE COMPARED TILL 3 MONTHS AFTER CLEARANCE. RESULTS: BETWEEN SEPTEMBER 2021 AND JULY 2022, 70 PATIENTS WERE RANDOMIZED INTO GROUP A, STENTING (N=35), AND GROUP B, NO STENTING (N=35). SIXTY-SIX PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS. BASELINE CHARACTERISTICS WERE COMPARABLE BETWEEN THE 2 GROUPS. TEN (15.2%) PATIENTS HAD RECURRENCE OF CHOLEDOCHOLITHIASIS, AND IT WAS COMPARABLE BETWEEN THE 2 GROUPS (7/34 [20.6%] AND 3/34 [9.4%], P=0.306). FIVE PATIENTS (2 CHOLECYSTITIS AND 3 POST-ERC PANCREATITIS) FROM THE STENT GROUP WHILE NONE FROM THE NO STENT GROUP DEVELOPED COMPLICATIONS, AND THIS DIFFERENCE WAS STATISTICALLY SIGNIFICANT (P=0.024). NONE OF THE PATIENTS IN BOTH THE GROUPS NEEDED EMERGENCY ERC DURING THE FOLLOW-UP. DISCUSSION: THIS RANDOMIZED TRIAL SHOWS A HIGHER COMPLICATION RATE WITH PROPHYLACTIC STENTING, WHILE THERE IS NO BENEFIT IN PREVENTING CHOLEDOCHOLITHIASIS RECURRENCE IN PATIENTS WAITING FOR CHOLECYSTECTOMY AFTER BILIARY CLEARANCE (CTRI REGISTRATION NUMBER: CTRI/2021/09/036538). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS [STENT GROUP]: EVENT 1: POST-ERC PANCREATITIS - 3 PATIENTS. EVENT 2: CHOLECYSTITIS - 2 PATIENTS. EVENT 3: RECURRENCE OF CHOLEDOCHOLITHIASIS - 7 PATIENTS. [NO STENT GROUP] RECURRENCE OF CHOLEDOCHOLITHIASIS - 3 PATIENTS. IN THE RANDOMIZED CONTROLLED TRIAL ¿ROLE OF BILIARY STENT IN RECURRENCE OF BILIARY STONES AND COMPLICATIONS AFTER STONE CLEARANCE IN PATIENTS AWAITING CHOLECYSTECTOMY¿ CAUSED POST ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS IN 3 PATIENTS, CHOLECYSTITIS IN 2 PATIENTS AND RECURRENCE OF CHOLEDOCHOLITHIASIS IN 7 PATIENTS AND RECURRENCE OF CHOLEDOCHOLITHIASIS IN 3 PATIENTS IN NO STENT GROUP. FIVE PATIENTS IN THE STENT GROUP WHILE NONE FROM THE NO STENT GROUP DEVELOPED COMPLICATIONS . OF THE 5 PATIENTS, 2 DEVELOPED CHOLECYSTITIS (FIRST, ON DAY 26 AND SECOND, ON DAY 14 POST-ERC). BOTH PATIENTS IMPROVED ON CONSERVATIVE MANAGEMENT. WHILE 3 PATIENTS DEVELOPED POST-ERC PANCREATITIS. TWO PATIENTS HAD MILD AND 1 HAD MODERATELY SEVERE DISEASE REQUIRING PERCUTANEOUS INTERVENTIONS FOR PANCREATIC COLLECTIONS, INTRAVENOUS ANTIBIOTICS, AND MULTIPLE ADMISSIONS. HYPERAMYLASEMIA WAS SEEN SIGNIFICANTLY MORE IN THE STENT GROUP (P 5 0.059). NO OTHER COMPLICATIONS RELATED TO ERC SUCH AS BLEEDING OR PERFORATION WAS NOTED IN BOTH THE GROUPS. POST-ERC, PATIENTS WERE STARTED ON A LIQUID DIET AFTER 4 HOURS OF OBSERVATION. ANY PERIPROCEDURAL COMPLICATIONS (POST-ERC PANCREATITIS, BLEEDING, PERFORATION, AND SEDATION RELATED) DEFINED AS PER THE EUROPEAN SOCIETY OF GASTROINTESTINAL ENDOSCOPY (ESGE) GUIDELINES FOR POST-ERC ADVERSE EVENTS WERE RECORDED IN CASE OF ANY PERIPROCEDURAL COMPLICATIONS, PATIENTS WERE ADMITTED AND MANAGED AS PER THE ESGE GUIDELINES. IF PATIENTS WERE STABLE DURING OBSERVATION, THEY WERE DISCHARGED AFTER 6 HOURS WITH ADVICE. TO CONTINUE LIQUIDS ON THE DAY OF THE PROCEDURE AND NORMAL DIET A DAY AFTER. DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) WAS PERFORMED AT 3 MONTHS OF ERC TO DETECT RECURRENCE OF CHOLEDOCHOLITHIASIS. THE ARTICLE REQUIRES ONE COMPLAINT FOR THE PATIENT IDENTIFIER: (B)(6)/TJF-Q180V. 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
    987291 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention