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); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

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 medical systems corporation received a literature titled "true diagnostic ability of eus-guided fine-needle aspiration/biopsy sampling for small pancreatic lesions =10 mm and salvage diagnosis by pancreatic juice cytology: a multicenter study".The study is aimed to clarify the diagnostic ability of eus-guided fine-needle aspiration/biopsy sampling (eus-fnab) and the salvage ability of pancreatic juice cytology (pjc) for pdac 10 mm.Data obtained from attempted eus-fnab for patients with eus-confirmed pancreatic tumors =10 mm (excluding pancreatic metastases/malignant lymphomas) were retrospectively analyzed.Patients who experienced technical failure or had a negative eus-fnab result and had a strong likelihood of pancreatic ductal adenocarcinoma (pdac) based on imaging characteristics underwent pjc.Pdac was diagnosed using resected histologic specimens, eus-fnab¿positive tumor growth on the imaging examination, or additional eus-fnab¿positive results after increase in tumor size.The primary endpoint was the diagnostic ability of eus-fnab for pdac =10 mm.The salvage ability of pjc was also assessed.Overall, 86 of 271 patients with pancreatic tumors =10 mm who underwent attempted eus-fnab were diagnosed with pdac.The technical success rate, sensitivity, specificity, and accuracy of eus-fnab for pdac =10 mm were 80.8%, 82.3%, 94.9%, and 91.3%, respectively.Among the 35 pdac patients who experienced technical failure or false-negative results of eus-fnab, 26 (74.3%) were correctly diagnosed using salvage pjc.The adverse event rates of eus-fnab and pjc were 2.4% (4 patients with pancreatitis and 2 with bleeding) and 4.1% (2 with pancreatitis), respectively.All adverse events were mild or moderate and improved with conservative treatment.The true success rate and sensitivity of eus-fnab for pdac =10 mm were relatively low.When eusfnab for a pancreatic lesion =10 mm strongly suspected to be pdac is unsuccessful or yields a negative result, pjc is recommended.Type of adverse events/number of patients pancreatitis (eus-fnab) (4 patients) bleeding (eus-fnab) (2 patients) pancreatitis (pjc) (2 patients) this report is related to patient identifier (b)(6).

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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• 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: 18636375
• MDR Text Key: 334494681
• Report Number: 3002808148-2024-01057
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 02/21/2024
• 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
• Patient Outcome(s): Required Intervention