MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number	SD-400U-10
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	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
In the literature titled ¿risk factors of delayed bleeding after cold snare polypectomy for colorectal polyps: a multicenter study,¿ patients experienced delayed bleeding (db) after cold snare polypectomy (csp) procedures using olympus devices.Case with patient identifier (b)(6) reports pcf-q260azi.Case with patient identifier (b)(6) reports pcf-q260ai.Case with patient identifier (b)(6) reports pcf-h290i.Case with patient identifier (b)(6) reports pcf-h290zi.Case with patient identifier (b)(6) reports cf-hq290i.Case with patient identifier (b)(6) reports sd-210l-10.Case with patient identifier (b)(6) reports sd-400u-10.Study background/aim: delayed bleeding (db) rarely occurs after cold snare polypectomy (csp) for colorectal polyps, but no large-scale studies have investigated this.The study evaluated the rate, characteristics, and risk factors of db of csp.Methods: a multicenter retrospective study at 10 japanese institutions.A total of 18,007 patients underwent csp for colorectal polyps = 10 mm in size from march 2015 to september 2019, and cases of db (db group) were analyzed for the rate, antithrombotic drugs, polyp size, morphology, location, and risk factors.As a control, 269 non-bleeding cases (non-db group) with 606 polyps who underwent csp at the same 10 facilities in the 2-week study period were extracted.Results: 26 db cases were analyzed with 28 lesions, and the total db rate was 0.14% (26/18,007).The db group had significantly higher rates of using antiplatelets (42.3% vs.13.0%, p < 0.001) and anticoagulants (19.2% vs.2.6%, p = 0.002), and significantly higher rates of polyp size = 5 mm (67.9% vs.45.2%, p = 0.015), rectal lesion (25.0% vs.6.6%, p = 0.003), and polypoid lesion (89.3% vs.55.3%, p < 0.001) than the non-db group.A multivariate analysis (odds ratio; 95% confidence interval) for patient characteristics showed antiplatelet use (4.521; 1.817¿11.249, p = 0.001) and anticoagulant use (7.866; 20.63¿29.988, p = 0.003) as independent risk factors for db.Polyp size = 5 mm (3.251; 1.417¿7.463, p = 0.005), rectal lesion (3.674; 1.426¿9.465, p = 0.007), and polypoid lesion (7.087; 20.81¿24.132, p = 0.002) were also risk factors for lesion characteristics.Conclusion: the rate of db was 0.14% and antithrombotic drug use, polyp size, location, and morphology were related to it.In all db cases, endoscopic clipping was performed to achieve hemostasis.There were no cases who received blood transfusion.Db occurred 0¿5 days after csp, with an average of 1.6 ± 1.3 days later.Db most frequently occurred on the first day after csp (57.7%).There is no report of olympus device malfunction described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.See update in g2.The device history record was unable to be reviewed for this device since the 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Common Device Name: ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13949622
• Report Number: 8010047-2022-05300
• Device Sequence Number: 20461555
• Product Code: FDI
• UDI-Device Identifier: 04953170396694
• UDI-Public: 04953170396694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172734
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: SD-400U-10
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/04/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown