MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number	KD-V451M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	06/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled, "visibility of the biliary orifice after precut papillotomy: comparison between white light imaging and texture and color enhancement imaging." literature summary background: precut papillotomy is performed in cases of difficult biliary cannulation, but identification of the biliary orifice is difficult.Texture and color enhancement imaging (txi) can enhance the structure, color, and brightness.This study compared txi and white light imaging (wli) in visibility of biliary orifices.Methods: we retrospectively examined 20 patients who underwent bile duct cannulation using both wli and txi after precut papillotomy at our center between 2021 and 2022.On wli and txi images displayed in random order, bile duct orifice on precut-incision surface of each image was independently evaluated by eight evaluators.Single-indication accuracy rate of biliary orifices, visibility score rated on a 4-grade scale, and color difference between the biliary orifice and the surrounding tissue were examined.Results: the single-indication accuracy rate was higher in txi compared to wli ((b)(4), odds ratio 2.26 [(b)(4) ci: 1.32¿3.89], p = (b)(4)).The time to indicate the biliary orifice was comparable between txi and wli (median, 9.7 s [range, 2.6¿43] vs.10.9 s [1.5¿64], p = (b)(4)).Furthermore, the visibility score was higher in txi than in wli (median, 3 [interquartile range, 2¿3] vs.2 [2, 3], p < (b)(4)), and the color difference between the biliary orifice and surrounding tissue in txi was more pronounced than in wli (median, 22.9 [range, 9.39¿55.2] vs.18.0 [6.48¿43.0]; p < (b)(4)).Conclusions: txi enhanced the color difference and visibility of the biliary orifice after precut and improved single-indication accuracy rate, suggesting that it could be useful for biliary cannulation after precut papillotomy.Type of adverse events/number of patients.Post-ercp pancreatitis: mild grade - (b)(4) patients.
Additional Manufacturer Narrative
The literature article can be found under doi: 10.1002/jhbp.12005.Since the literature described "needle cut 3 v", olympus selected "kd-v451m" as a representative product.This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and 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 3-LUMEN NEEDLE KNIFE V
• Common Device Name: SINGLE USE 3-LUMEN NEEDLE KNIFE
• 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: 20364328
• Report Number: 9614641-2024-01921
• Device Sequence Number: 20548029
• Product Code: KNS
• UDI-Device Identifier: 04953170382710
• UDI-Public: 04953170382710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: KD-V451M
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown