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

Model Number SD-400U-10

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

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 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
• Type of Device: 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: 10222329
• MDR Text Key: 202862111
• Report Number: 8010047-2020-03824
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170396694
• UDI-Public: 04953170396694
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-400U-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1