MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. PRECUTTING KNIFE; PRE-CUTTING KNIFE

Model Number	KD-10Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
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.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, "comparison of anticoagulants and risk factors for bleeding following endoscopic sphincterotomy among anticoagulant users: results from a large multicenter retrospective study".Background and aim bleeding is an inevitable and often severe complication after endoscopic sphincterotomy (est).We aimed to investigate the factors associated with post-est bleeding in patients treated with anticoagulants.Methods the data of patients who underwent est at 15 hospitals between july 2015 and june 2017 were extracted.We investigated the incidence of post-est bleeding and risk factors for bleeding in patients treated with anticoagulants.Results one hundred forty-nine patients undergoing est who met the inclusion criteria were included in this study.The total-est bleeding (bleeding occurring during or after est) rate did not differ between the heparin replacement (8.0%, 6/75) and continuation (16.6%, 2/12; p = 0.37) groups of warfarin users.The total-est-bleeding rate in the heparin replacement group (12.9%, 4/31) was significantly higher than that in the continuation group (0%, 0/31; p = 0.016) in direct oral anticoagulant (doac) users.The rate of total-est bleeding with continuation of doac (0%, 0/31) was significantly lower with continuation of warfarin (16.6%, 2/12; p = 0.021).During-est bleeding (bleeding occurring during est) (p = 0.0083) and precut (p = 0.033) were significant risk factors for post-est bleeding in all 149 patients.Heparin replacement was only a significant risk factor for total-est bleeding (p = 0.033) in doac users.Conclusion heparin replacement was a significant risk factor for post-est bleeding in doac users; however, there was no significant difference between the bleeding rate of heparin replacement and that of continuation groups in patients taking warfarin.During est and precut were significant risk factors for post-est bleeding in all patients treated with anticoagulants.Type of adverse events/number of patients during-est bleeding (warfarin and doac groups) - 6 patients.Post-est bleeding (warfarin and doac groups) - 6 patients.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6).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 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: PRECUTTING KNIFE
• Common Device Name: PRE-CUTTING 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: 16687134
• Report Number: 9614641-2023-00475
• Device Sequence Number: 6111995
• Product Code: KNS
• UDI-Device Identifier: 04953170038051
• UDI-Public: 04953170038051
• 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): 05/04/2023

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-10Q-1
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown