MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Gastrointestinal Hemorrhage (4476)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-01021.This report is related to the following linked patient identifier: (b)(6).Since the literature described "ez shot 3 plus, olympus selected "na-u200h-8022" as a representative product.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled ¿comparing needles and methods of endoscopic ultrasound-guided fine-needle biopsy to optimize specimen quality and diagnostic accuracy for patients with pancreatic masses in a randomized trial¿.Background & aims: given the lack of procedure standardization, findings vary from analyses of pancreatic tissues collected by endoscopic ultrasound¿guided fine-needle biopsy.It is not clear which needle and technique yield the best specimen for analysis.We compared the specimen quality and accuracy of diagnoses made from samples collected by fine-needle biopsy needles using different collection techniques.Methods: patients found to have pancreatic masses during imaging (n 129) were assigned randomly to groups from whom pancreatic tissue samples were collected by reverse-bevel, menghini-tip, franseen, or fork-tip needles.A second randomization determined the technical sequence of biopsies in each patient (suction, no suction, and stylet retraction).Two independent pathologists, blinded to the type of needle and sampling technique, analyzed all the samples.Final diagnoses of malignancy were made based on surgical resection, death from cancer progression, or findings from radiology or clinical follow-up evaluations (reference standard).The primary objective was to compare the cellularity of the samples collected, defined as the proportion of core tissue in the biopsy sample.Secondary objectives were to compare the accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity.Results: one-hundred and nine patients had a final diagnosis of malignancy (84.5%) and 20 patients had benign disease (15.5%).Samples collected by fork-tip or franseen needles had significantly higher cellularity than samples collected by reverse-bevels or menghini-tip needles (p <.001).Neoplasias were identified with greater than 90% accuracy using samples collected by fork-tip or franseen needles (p <.001 compared with other needles).On multivariable regression analysis, use of franseen needles (odds ratio [or], 4.42; 95% ci, 2.58¿7.58; p <.001) or fork-tip needles (or, 3.86; 95% ci, 2.24¿6.64; p <.001), stylet retraction (or, 2.13; 95% ci, 1.21¿3.72; p [.008), no suction (or, 2.74; 95% ci, 1.57¿4.80; p <.001), and pancreatic mass larger than 3 cm (or, 1.92; 95% ci, 1.21¿3.05; p [.005) were associated with high cellularity of the sample.Conclusions: in patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in a diagnostic accuracy of 90% of higher, were collected by fine-needle biopsy using the franseen or fork-tip needle.Type of adverse events/number of patients: postprocedural abdominal pain requiring hospital admission for observation (1 patient) upper gastrointestinal bleed from a malignant duodenal ulcer (1 patient) self limiting mucosal bleeding during biopsy (1 patient) upper gastrointestinal bleed 2 days after biopsy (1 patient) postprocedural abdominal pain requiring emergency room visit (1 patient).
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d8, h6 the device has not been returned to olympus for evaluation.¿based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.¿should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20847547
• Report Number: 9614641-2024-20048
• Device Sequence Number: 18167888
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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-U200H-8022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown