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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled, "clinical benefit of early precut sphincintroterotomy for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography" objectives a precut procedure is sometimes required for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ercp).However, it is unclear whether the biliary access rate has improved for early precut procedures compared to conventional techniques.This study aimed to identify the beneft of early precut sphincterotomy in cases showing difcult biliary access.Methods between april 2017 and august 2021, consecutive patients who underwent precutting for difcult biliary cannulation were retrospectively enrolled.The outcomes of early (=10 min from start of cannulation) and delayed (>10 min) precut groups were evaluated.All adverse events were defned according to cotton criteria.Results a total of 70 patients were enrolled in this study.The biliary cannulation rate for a frst ercp was signifcantly higher in the early compared to delayed precut group (95% vs.73.3%; p=0.015).A diference in overall cannulation rate between the two groups was not observed (97.5% vs.83.3%; p>0.05).Signifcantly higher rates of prophylactic pancreatic stents were described in the delayed compared to early precut group (36.7% vs.12.5%; p=0.009).Signifcant diferences in the frequency of pancreatitis, bleeding, penetration, and perforation were not noted between the two groups.Overall, the success rate was statistically signifcant between the experienced and less experienced endoscopists (87.2% vs.63.9%; p=0.017).Conclusions early precutting within 10 min from the start of cannulation in ercp is safe and efective in cases with a diffcult biliary cannulation, and can improve the biliary cannulation rate.Type of adverse events/number of patients (early precut) post-ercp pancreatitis - 3 patients bleeding - 2 patients retroperitoneal penetration - 1 patient (delayed precut) post-ercp pancreatitis - 3 patients bleeding - 2 patients retroperitoneal penetration - 1 patient this literature article requires 2 reports.The related patient identifiers are as follows: 1.(b)(6)/tjf-260v 2.(b)(6)/kd-v451m this medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
Since the literature described "needle cut 3 v" we selected "kd-v451m" which were shipped the most in the area and in the study period, were used.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6).2.(b)(6).3.(b)(6).
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 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: 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: 16640695
• Report Number: 9614641-2023-00447
• Device Sequence Number: 5368035
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: KD-V451M
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS: CANNULA; NON-OLYMPUS: ERBE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown