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

Model Number	NA-200H-8022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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 56% were men.The most common presenting symptoms were abdominal pain (37%) and jaundice (29%).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 (64%) with localized disease, of whom 115 (58%) had resectable lesions, 61 (31%) had borderline resectable, and 21 (11%) 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 (1%) 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.
Additional 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.An importer medwatch report has been submitted on report #2429304 - 2023 - 00037.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional 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: 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16508235
• Report Number: 9614641-2023-00344
• Device Sequence Number: 5849566
• Product Code: FCG
• UDI-Device Identifier: 04953170169977
• UDI-Public: 04953170169977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown