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 Problems Abscess (1690); Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/02/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "unilateral versus bilateral y-type stent-in-stent metal stent insertions in inoperable malignant hilar biliary strictures: a multicenter retrospective study." this multicenter retrospective was to compare the clinical outcomes and complications of unilateral and bilateral (stent-in-stent method) stent placements for these patients.A total of 236 subjects were included.The technical success rate was 98.8% in the unilateral group and 82.5% in the bilateral group.However, the clinical success rate of bilateral group was superior to that of unilateral group.There were no differences in the composition of early and late complications between the two stent groups, either.The multivariate analysis showed a higher risk of death in the cases of compression by lymph nodes and higher crp and lower risk in those with bilateral self-expandable metal stent (sems) insertions.In conclusion, y-type stent-in-stent bilateral semss are technically difficult but demonstrated more favorable overall survival for palliative bile drainage of inoperable malignant hilar biliary strictures (mhbs) patients compared to unilateral insertions.Type of adverse events/number of patients: pancreatitis (28); cholangitis (8); cholecystitis (1); bleeding (3); perforation (1); hemobilia (2); abscess (4); death(104).This literature requires 2 reports.The related patient identifiers are as follows: (b)(6) - death.(b)(6) - adverse events.This report is for (b)(6).

Manufacturer Narrative

H6 appropriate terms: cholecystitis, hemobilia.This device has not been returned for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus further received information that there was no olympus device malfunction during the procedure described in the literature.Additionally, the olympus device did not cause or contribute to any of the patient adverse events including deaths described in the literature.

Manufacturer Narrative

This report is being supplemented to provide additional information from the author/customer.

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.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.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: 17441849
• MDR Text Key: 320216173
• Report Number: 9610595-2023-11000
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/27/2023

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: 07/11/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/04/2023; 09/20/2023
• Supplement Dates FDA Received: 08/04/2023; 09/27/2023
• 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