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

Model Number	KD-620LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Thromboembolism (2654)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported in the literature titled ¿predictive model for bleeding after gastric submucosal dissection before and after guidelines: a single-center retrospective study,¿ patients experienced adverse events after endoscopic submucosal dissection procedures.Background: in july 2017, supplementary guidelines on anticoagulants, including direct oral anticoagulants, were published in japan.We investigated the changes in endoscopic submucosal dissection (esd) of gastric mucosal lesions after the publication of the supplement, examined the risk factors, and developed a predictive model for post-esd bleeding.Methods: we included 2272 gastric esd cases from our hospital between may 2003 and june 2021 and classified them into two groups: 1789 cases before and 483 after the publication of the supplementary guidelines.A predictive model for post-esd bleeding was developed using the pre-publication cohort data.Results: the proportion of patients receiving warfarin decreased (5.0% vs.1.4%) and those receiving direct oral anticoagulants increased (1.2% vs.6.8%) after the publication of the supplementary guidelines.Post-esd bleeding occurred in 61 patients, but there was no significant difference in the bleeding rate between the groups (50 [2.8%] vs.11 [2.3%] patients, respectively).Five risk factors (number of antithrombotic agents, dialysis, heparin replacement, resection specimen size, and procedure time) were identified for model development.The c-statistic for the model and post-publication cohorts were 0.83 and 0.72, respectively.In the model, each risk factor for postoperative bleeding was scored, and the risk was classified into three levels according to the total score.Bleeding rates at low, intermediate, and high risks were 1.6%, 10.3%, and 38.9%, respectively.Conclusion: despite changes in patient characteristics and clinical practice regarding esd before and after the publication of the supplementary guidelines, we could still develop a simple and useful predictive model.A comparison of outcomes between the groups (pre-publication and post publication) was performed.Although the perforation rate decreased, there was no change in the incidence of post-esd bleeding.The overall post-esd bleeding rate was 2.68% (61/2272).Two cases of thromboembolism associated with withdrawal of anticoagulant agents accounted for 1.28% (2/152) of patients administered anticoagulants.There is no information provided regarding the cause of death for patients who died in the study period.Case with patient identifier (b)(6) reports adverse events kd-650l.Case with patient identifier (b)(6) reports death kd-650l.Case with patient identifier (b)(6) reports adverse events kd-620lr.Case with patient identifier (b)(6) reports death kd-620lr.Case with patient identifier (b)(6) reports adverse events kd-610l.Case with patient identifier (b)(6) reports death kd-610l.The author confirmed there was no olympus device malfunction in any procedure described in this literature.Additional questions were asked and left unanswered by the author.
Additional Manufacturer Narrative
This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information added to h6.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15294196
• Report Number: 9614641-2022-00203
• Device Sequence Number: 20415715
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• 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: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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-620LR
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown