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

Model Number	SD-400U-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled ¿cold snare piecemeal endoscopic mucosal resection of large sessile colonic polyps =20 mm (with video)¿.The literature reported the result of 186 patients of the cold snare piecemeal endoscopic mucosal resection (csp-emr) procedure using olympus single use electrosurgical snare sd-400u-10 or non-olympus ref-00711115 (us endoscopy) from january 2016 to december 2017.In the subject cases, 7 cases of clinically significant post-emr bleeding occurred.There was no information on which model was used in which procedure.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Therefore, omsc will submit a medical device reports (mdr) depending on the type of adverse events.

• 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
• MDR Report Key: 10222329
• Report Number: 8010047-2020-03824
• Device Sequence Number: 573040
• Product Code: FDI
• UDI-Device Identifier: 04953170396694
• UDI-Public: 04953170396694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,user facil
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: No Information
• Device Model Number: SD-400U-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1