MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pancreatitis (4481); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "very urgent endoscopic retrograde cholangiopancreatography is associated with early discharge in patients with non-severe acute cholangitis".Literature summary background: endoscopic retrograde cholangiopancreatography (ercp) is a first-line procedure for biliary drainage in patients with acute cholangitis, and there are no studies focused on very urgent ercp within several hours of hospital arrival.This study aimed to elucidate the use of very urgent ercp for non-severe acute cholangitis.Methods: this retrospective observational study included patients with non-severe acute cholangitis who underwent ercp between april 2011 and june 2020 in our institution.Patients were stratified into three groups based on time to ercp after hospital arrival: very urgent (= 3 hours), urgent (3-24 hours) and elective (> 24 hours).The primary outcome was length of hospital stay (los).Results: this retrospective, observational cohort study was to elucidate the use of very urgent endoscopic retrograde cholangiopancreatography (ercp) as performed within = 3 hours after hospital arrival for non-severe acute cholangitis (ac), by comparing with ercp as performed > 3 hours after hospital arrival.A total of 291 patients were included (47 patients (very urgent group), 196 patients (urgent group), and 48 patients (elective group).A shorter los was associated with earlier ercp (log-rank trend test, p = 0.04).The rates of readmission within 30 days of discharge and of adverse events were not significantly different among the three groups.The multivariate analysis showed that, compared with the very urgent group, the hrs were significantly lower in the urgent (hr, 0.71, p = 0.04) and elective (hr, 0.47, p < 0.01) groups.Very urgent ercp for non-severe acute cholangitis was associated with early discharge.Conclusions: very urgent ercp for non-severe acute cholangitis was associated with early discharge.Type of adverse events/number of patients very urgent readmission within 30 days of discharge - 3 patients pancreatitis - 3 patients acute cholecystitis - 1 patient urgent pancreatitis - 11 patients readmission within 30 days of discharge - 5 patients elective readmission within 30 days of discharge - 1 patient pancreatitis - 2 patients this literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6)- tjf-240.2.(b)(6)- jf-260v.3.(b)(6)- tjf-q290v.This medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

H6 - code 4581 is used to reflect acute cholecystitis.The suspect device has not been returned to olympus.Additional information is being requested.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

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.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17082969
• MDR Text Key: 316845292
• Report Number: 9610595-2023-08552
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other