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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "risk of delayed bleeding after cold snare polypectomy in patients with antithrombotic therapy".Literature summary: this study aimed to investigate the real-world safety of cold snare polypectomy during antithrombotic therapy.Based on the collected data from consecutive patients undergoing cold snare polypectomy in a single hospital between 2013 and 2017.Indications for cold snare polypectomy were any = 10 mm polyp.The primary outcome was delayed bleeding.This was compared rates of delayed bleeding between patient with and without antithrombotic therapy and analyzed risk factors for delayed bleeding using binary logistic regression model with firth procedure.Delayed bleeding occurred in 11 patients out of 2, 152 patients.The rate of delayed bleeding was higher in patients on antithrombotic therapy.Patients on antithrombotic therapy were older more likely male patients and had cold snare polypectomy.Larger polyps¿ size (>5mm), use of clips and antithrombotic therapy were significant risk factors for delayed bleeding.However, there was no clear association between specific antithrombotic agents and delayed bleeding.Conclusion: delayed bleeding after cold snare polypectomy was rare even in patients with antithrombotic therapy, and no major delayed bleeding occurred.The following devices were used to perform the colonoscopy procedures: olympus colonoscopes model pcf-h290azl and pcf-hq290i.Fuji film¿s device model ec-l600zp and ec-l590zw.The snare used for csp was captivator 13mm boston scientific, and snare master 10mm manufactured by olympus (sd-400u-10).Based on the literature, there was no allegations of device malfunction; however, olympus will be filing four mdrs based on the four (4) out of 11 patients that reportedly experienced delayed bleeding after undergoing the csp and a clipping device was utilized to control the bleeding.Although, the literature did not specify which of the olympus devices were used on which patients, olympus decided to submit mdrs on the snare master 10mm, as this is the device that had close contact on the bleeding site.Cross-reference the following related complaints with patient identifier number: (b)(6): sd-400u-10.(b)(6): sd-400u-10.(b)(6): sd-400u-10.(b)(6): sd-400u-10.
Additional Manufacturer Narrative
(b)(6).No device was returned to olympus for investigation.Olympus contacted the author to obtain additional information regarding this report, and according to the author, there was no reported device malfunction and that they do not alleged the olympus device(s) to have caused or contributed to the reported event.This report is being submitted in an excess of caution and to specifically account to the delayed bleeding cases that required a clipping device to control the reported bleeding.This report will be supplemented when new and relevant information becomes available at a later.
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 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: 13961907
• Report Number: 8010047-2022-05420
• Device Sequence Number: 4176861
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 04/05/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FUJI FILM¿S DEVICE MODEL EC-L600ZP AND EC-L590ZW.; PCF-H290AZL SERIAL NUMBER UNKNOWN.; PCF-HQ290I SERIAL NUMBER UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male