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

Model Number	KD-V441M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "cutting knife", olympus selected "kd-v441m" which was shipped the most in the area and in the study period.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Https://doi.Org/10.1007/s00464-021-09000-0 once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled "the assessment of the asge-grading system of ercp: a large-sample retrospective study." this retrospective study aimed to assess the association between the degree of difficulty for ercp and the rates of success and adverse event, in turn demonstrating the validity and practicality of this system.A total of 20,652 ercp procedures performed during the study period were analyzed.The overall success rate increased from 92.8% to 94.0%, while the distribution of procedures and the incidence of complications showed little variation.The success rate revealed a significantly decreasing trend with increasing difficulty (ranging from 55.6 to 98.6%), mainly for biliary diseases.In addition, the difficulty scale was not associated with any differences in the rate of adverse event, except for the pancreatitis for grade 1 procedures, which had a low incidence.This study concluded that the asge-grading system can help predict the success rate of ercp procedures but showed poor performance in predicting adverse events.Type of adverse events/number of patients: cohort - 1.Pancreatitis - 511 patients.Bleeding - 410 patients.Cholangitis - 62 patients.Perforation - 26 patients.Cohort - 2.Pancreatitis - 536 patients.Bleeding - 412 patients.Cholangitis - 83 patients.Perforation - 32 patients.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6)/kd-v441m, (b)(6)/jf-240 and (b)(6)/jf-260v.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
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.This supplemental report includes information added to e4.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15770768
• Report Number: 9614641-2022-00588
• Device Sequence Number: 4973120
• Product Code: KNS
• UDI-Device Identifier: 04953170382703
• UDI-Public: 04953170382703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/19/2022

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-V441M
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/19/2022
• 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 BALLOON, SN UNKNOWN; NON- OLYMPUS BASKET, SN UNKNOWN; NON- OLYMPUS C-ARM ERCP X-RAY, SN UNKNOWN; NON- OLYMPUS GUIDEWIRE, SN UNKNOWN; OLYMPUS JF-240, TJF-240 OR JF-260V, SN UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown