MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ULTRATHIN VIDEOSCOPE; CHOLEDOCHO FIBERSCOPE

Model Number CHF-B260

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

Patient Problem Pancreatitis (4481)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Olympus reviewed the literature titled "innovative method for the diagnosis of bile duct lesions using a novel tapered-tip sheath system to facilitate biliary biopsies." background and aims: pathologic evaluation of bile duct lesions is crucial for a definitive diagnosis and determination of an appropriate therapeutic strategy; however, current methods are limited by several challenges.This study evaluated the impact of a novel tapered-tip sheath system on biliary stricture diagnosis.Methods: this observational study evaluated 47 consecutive patients who underwent transpapillary biliary stricture biopsy using the novel tapered-tip sheath system from july 2020 to march 2022 compared with 51 historical control subjects undergoing conventional biopsies.Technical success rate, total biopsy time, number of biopsy specimens, adequate tissue sampling rate, adverse events, and diagnostic performance for biliary strictures were assessed.Results: the technical success rate was favorable in both groups, showing no significant difference (97.9% [46 of 47] vs 88.2% [45 of 51], p z.114).However, the total biopsy time was significantly shorter in the novel system group (3.7 vs 7.7 minutes, p <.001).The number of biopsy specimens did not differ between the groups; however, the novel system group had significantly more cases in which 3 tissue samples could be obtained (71.7% [33 of 46] vs 51.1% [23 of 45], p z.043), a higher adequate tissue sampling rate (88.2% vs 66.4%, p <.001), and fewer adverse events (6.4% vs 21.6%, p z.043).Although the diagnostic specificity of both groups was 100%, the novel system group had significantly higher diagnostic sensitivity and accuracy (82.1% vs 50% [p z.004] and 84.8% vs 55.5% [p z.005], respectively).Conclusions: the novel tapered-tip sheath system is a promising tool for biliary stricture diagnosis.Type of adverse events/number of patients: acute pancreatitis (mild=10, moderate=1, severe=2) cholangitis (1) there are three related patient identifiers: (b)(6) :tjf-260v (evis lucera duodenovideoscope) (b)(6) :chf-b260 (evis lucera ultrathin videoscope) (b)(6) :um-g20-29r (ultrasonic probe) this medwatch is for (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation.The literature article is attached for additional information.Doi.Org/10.1016/j.Gie.2023.02.005 provided for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The author reported that the events described in the article were not caused by an olympus product.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the author.B5 has been updated accordingly.Based on the additional information received from the author, there is no change to the previously reported legal manufacturer investigation findings.

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.

• Brand Name: EVIS LUCERA ULTRATHIN VIDEOSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• 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: 18647888
• MDR Text Key: 334620386
• Report Number: 9610595-2024-02503
• Device Sequence Number: 1
• Product Code: FBN
• 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: 03/19/2024

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: CHF-B260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 03/14/2024
• Supplement Dates FDA Received: 03/12/2024; 03/19/2024
• 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
• Treatment: TJF-260V (EVIS LUCERA DUODENOVIDEOSCOPE); UM-G20-29R (ULTRASONIC PROBE)
• Patient Outcome(s): Other