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 Hemorrhage/Bleeding (1888); Pneumonia (2011); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

The literature listed "jf-260v" and "tjf-260v," olympus selected jf-260v as the representative device because both are in the evis lucera series.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.

Event Description

Olympus reviewed the following literature titled "efficacy and safety of endoscopic removal for asymptomatic common bile duct stones in comparison with symptomatic stones".This retrospective study compared the efficacy and safety of cbds removal in asymptomatic and symptomatic patients.There were 300 patients enrolled (53 asymptomatic and 247 symptomatic patients).Endoscopic cbds removal was successful in all patients, except one symptomatic patient.However, the complete stone removal rate in a single session was significantly higher in the asymptomatic group than that in the symptomatic group.Ercp-related complications did not differ between the asymptomatic and symptomatic patients.The incidence of post-ercp pancreatitis was similar and liver cirrhosis was the only significant risk factor for pancreatitis.This study concluded that the risks associated with endoscopic cbds removal was not significantly different between asymptomatic and symptomatic patients.Liver cirrhosis was a significant risk factor of ercp-related pancreatitis.Type of adverse events/number of patients: pancreatitis - 7 patients, hyperamylasemia - 28 patients, bleeding - 2 patients, cholangitis - 14 patients, aspiration pneumonia - 2 patients.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was not returned to olympus for evaluation.Based on the results of the investigation, as no malfunction of the subject device was reported, and from a clinical/medical evaluation and risk assessment, it is presumed that the reported events were either due to an accident or a complication associated with the surgical procedure using the subject device.In addition, the corresponding author of the literature is no longer affiliated with the hospital listed in the literatures.Since the author's new affiliation is unknown, we were unable to investigate further.Therefore, it is not possible to identify the root cause of the reported events.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: 15821179
• MDR Text Key: 303892332
• Report Number: 9610595-2022-04191
• 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: 12/08/2022

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: 10/23/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/08/2022
• 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): Hospitalization; Other