MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Aspiration Pneumonitis (4455); Pancreatitis (4481)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

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, "diagnostic ability of endoscopic ultrasound-guided tissue acquisition using 19-gauge fine-needle biopsy needle for abdominal lesions." attempts at performing endoscopic ultrasound-guided tissue acquisition (eus-ta) with a 19g needle are increasing because histological diagnosis and comprehensive genomic profiling are a necessity.However, the diagnostic ability of the 19g fine-needle biopsy (fnb) needle, especially the third-generation fnb needle, is unclear and has been retrospectively reviewed.The 19g topgain needle was used in 147 patients and 160 lesions between september 2020 and december 2021.The technical success rate of the biopsies was 99.4% (159/160).The early adverse event rate was 4.1% (6/147), and moderate or severe adverse event rate occurrence was 2.0% (3/147).The sensitivity, specificity, and accuracy of the 19g topgain needle for 157 lesions with a confirmed diagnosis were 96.7%, 100%, and 96.8%, respectively.Rescue eus-ta using the 19g topgain needle was performed for nine lesions, and a successful diagnosis was made in six of these lesions (66.7%).The diagnostic ability of eus-ta using the third-generation 19g topgain needle was favorable.However, the use of 19g fnb needles may increase adverse events.Therefore, eus-ta with a 19g fnb needle is mainly indicated in lesions where comprehensive genomic profiling may be necessary or the diagnosis could not be determined via eus-ta using the 22g needle.Types of adverse events/ number of patients: bleeding, n=2; intra-abdominal infection, n=2; pancreatitis, n=1; aspiration pneumonia, n=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.This supplemental report includes new information received from the author.B5 updated.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received from the author: the adverse events described in the article were not caused by an olympus device.Also, an olympus device did not malfunction in any of the procedures described in the article.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16482678
• MDR Text Key: 310683167
• Report Number: 3002808148-2023-02111
• Device Sequence Number: 1
• Product Code: ODG
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2023
• 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): Required Intervention; Other