MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "dual knife," kd-650q was selected as the representative model.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.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "the management of direct oral anticoagulants for colorectal endoscopic submucosal dissection: a multicenter observational study".Literature summary.Background: there is a lack of reports on the use of direct oral anticoagulants (doacs) during colorectal endoscopic submucosal dissection (esd).Aims: we aimed to assess whether the use of doacs is associated with a higher incidence of delayed bleeding (db) after esd.Methods: a total of 4175 colorectal neoplasms in 3515 patients were dissected at our hospitals during study period.We included 3909 lesions in the final analysis.The lesions were divided into two groups: the no-at group (3668 neoplasms) and the doac group (241 neoplasms).We also compared the doac withdrawal group (154 neoplasms) and the doac continuation group (87 neoplasms).Results: among the 3909 lesions, db occurred in a total of 90 cases (2.3%).The rate of db was 2.2% (82/3668), and 3.3% (8/241), respectively.There were no significant differences in the rate of db between the no-at group and the doac group.In the doac group, there were no significant differences in the rate of db between the withdrawal group (5.2%, 8/154) and the continuation group (0%, 0/87).The multivariable analysis identified the location of the lesion in the rectum (odds ratio [or], 4.04; 95% confidence interval [ci], 2.614¿6.242; p < 0.001) and lesions = 30 mm in diameter (or, 4.14; 95% ci, 2.349¿7.34; p < 0.001) as independent risk factors for db.Conclusions: our findings suggest that doac use has no significant important on the rate of db.Prospective studies are warranted to determine whether treatment with doacs should be interrupted prior to colorectal esd.Type of adverse events/number of patients.[no-at agent group].Delayed bleeding - 82 patients.Perforation - 56 patients.Post-esd coagulation syndrome (pecs) - 66 patients.[direct oral anticoagulant (doac) group].Delayed bleeding - 8 patients.Perforation - 5 patients.Post-esd coagulation syndrome (pecs) - 8 patients.
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 ELECTROSURGICAL KNIFE KD-650
• Common Device Name: SINGLE USE ELECTROSURGICAL 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: 19394596
• Report Number: 9614641-2024-01157
• Device Sequence Number: 20773904
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• 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): 06/19/2024

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-650Q
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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: EVIS LUCERA COLONOVIDEOSCOPE. PCF-Q260JI; GASTROINTESTINAL VIDEOSCOPE GIF-H290T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown