MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE; GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE

Model Number	NA-200H-8022
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Pancreatitis (4481)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled, "a decade's experience of managing suspected pancreatic adenocarcinoma at a tertiary cancer center".Background we present our experience and established management strategy for endoscopic ultrasonography-guided fine-needle aspiration (eus-fna) in diagnosing suspected pancreatic neoplasms at a tertiary referral cancer hospital.Method relevant data were extracted from our database for patients who underwent eus-fna for suspected pancreatic neoplasms at our institution between 2007 and 2016.Results among the 309 patients, the median age was 67 years and (b)(4) were men.The most common presenting symptoms were abdominal pain (b)(4) and jaundice (b)(4).Concordance between radiographic diagnosis and final pathology was 89%.The mean lesion size was 34.9 mm on computed tomography and 31.5 mm on eus.There were 197 patients (b)(4) with localized disease, of whom 115 (b)(4) had resectable lesions, 61 (b)(4) had borderline resectable, and 21 (b)(4) had unresectable lesions (mean ca 19-9 levels 1705 u/ml, 2490 u/ml, and 479 u/ml, respectively).A median of 3 fna passes were performed to establish a pathologic diagnosis.Two patients (b)(4) had postprocedural adverse events.Median overall survival was 47 months in those who underwent surgery after eus and 12 months in those who did not (p<0.001).Conclusions a multidisciplinary approach is employed for management of suspected pancreatic neoplasm at our tertiary cancer center.A combination of cross-sectional imaging and eus-fna serves as a highly effective duo in establishing a tissue diagnosis and staging with a low adverse event rate.Counterintuitively, ca 19-9 is not necessarily higher with resectable lesions than with unresectable lesions, indicating the limitation of ca 19-9 as a pancreatic tumor marker.Type of adverse events/number of patients abdominal pain, nausea and vomiting (emergency room care) - 1 patient (non-serious) mild pancreatitis x 3 days - 1 patient there is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 16508121
• Report Number: 2429304-2023-00037
• Device Sequence Number: 6758631
• Product Code: FCG
• UDI-Device Identifier: 04953170169977
• UDI-Public: 04953170169977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2023
• Report Date (Section F): 02/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: NA-200H-8022
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS DEVICE: NEEDLES
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown