MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-210U-15
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	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "snaremaster", olympus selected "sd-210u-15" as the representative model as this was shipped the most in the area and in the study period.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifier: (b)(6).
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled "colorectal post-polypectomy bleeding in outpatient versus inpatient treatment: propensity score matching analysis".Literature summary objectives: delayed bleeding is the most frequent adverse event associated with endoscopic mucosal resection (emr) and hot snare polypectomy (hsp) of colorectal polyps.However, whether the incidence of delayed bleeding differs between outpatient and inpatient treatment is unknown.Therefore, in this study, we aimed to evaluate delayed bleeding rates between outpatient and inpatient endoscopic treatments and clarify the safety of outpatient treatment.Methods: we enrolled 469 patients (1077 polyps) and 420 patients (1080 polyps) in the outpatient and inpatient groups, respectively, who underwent emr or hsp for colorectal polyps at our institution between (b)(6) 2023.Using propensity score matching, we evaluated the delayed bleeding rates between the two groups.Delayed bleeding was defined as a hemorrhage requiring endoscopic hemostasis occurring within 14 days of the procedure.Results: propensity score matching created 376 (954 polyps) matched patient pairs.The median maximum diameter of polyps removed was 10 mm in both groups.Delayed bleeding rates per patients were 1.3% (5/376) in the outpatient group and 2.9% (11/376) in the inpatient group (p=0.21).In term of per polyp, early delayed bleeding (occurring within 24 hours) rates were higher in the inpatient group than outpatient group (0.2% [2/954] vs.1.1% [10/954], respectively; p=0.04).No severe bleeding requiring a transfusion occurred in either group.Incidence of delayed bleeding and time of occurrence a total of 21 patients developed delayed bleeding, with an average bleeding time of 2.6 days after treatment (range 1-6).Eight patients (53.3%) in the inpatient group developed bleeding within 1 day (early delayed bleeding), most of whom underwent endoscopic hemostasis while in the hospital.In five of these eight cases, patients were taking antithrombotic agents.Conclusions: outpatient endoscopic treatment did not increase delayed bleeding compared with inpatient treatment.Outpatient treatment would be safe and common for the removal of colorectal polyps.Type of serious adverse events/number of patients delayed bleeding - 21 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: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• 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: 20145753
• Report Number: 9614641-2024-01773
• Device Sequence Number: 8301331
• Product Code: FDI
• UDI-Device Identifier: 04953170298424
• UDI-Public: 04953170298424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902735
• 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): 10/22/2024

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: SD-210U-15
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown