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

Model Number TJF-260V

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

Patient Problem Pancreatitis (4481)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.Additional information has been requested but no information could be provided.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "usefulness of the novel snare-over-the-guidewire method for transpapillary plastic stent replacement (with video)".Literature summary: this single-center retrospective study aimed to compare the usefulness of the two methods: the snare-over-the-guidewire (sog) method and the side-of-stent (sos) method.A total of 244 patients were included (61 patients in sog group and 183 patients in sos group).In the sos group, the percentage of straight-type pss was 30.0%, while in the sog group, it was 100.0% (p < 0.001).The procedural success rate in the sog group was significantly higher than that in the sos group (90.2% vs.77.1%, p = 0.026).The time required for ps removal (seconds) was significantly shorter in the sog group than in the sos group (306 s vs.375 s, p = 0.012).Multivariate analysis also showed that the sos method (odds ratio (or) 3.64, 95% confidence interval (ci) 1.48¿10.46, p = 0.0038) and the presence of proximal biliary stenosis (or 5.08, 95% ci 2.37¿11.21, p < 0.0001).The sog method may be a very useful procedure for ps placement with possible re-intervention.Type of adverse events/number of patients post-procedure pancreatitis (1) 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 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 event 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.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the author as reflected in b5.

Event Description

Additional information was received indicating that the author has confirmed that the adverse events were not related to the olympus device and that there was no malfunction of the olympus 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: 17468937
• MDR Text Key: 320482298
• Report Number: 9610595-2023-11219
• 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,Followup
• Report Date: 09/22/2023

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: TJF-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: 07/10/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/21/2023; 09/20/2023
• Supplement Dates FDA Received: 08/30/2023; 09/22/2023
• 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