MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-221U-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
Event or Problem Description
On september 14, 2020, olympus medical systems corp.(omsc) received literature titled "impact of the clip and snare method using the prelooping technique for colorectal endoscopic submucosal dissection".This study was conducted the endoscopic submucosal dissection (esd) for colorectal tumors on 140 patients between january 2010, and may 2014.The subject device and the clips were used during the esd.In the literature, it was reported that complications of 4 cases of perforation and 7 cases of postoperative bleeding were occurred during the colorectal esd using the subject device.There are no descriptions of device relevance for the postoperative bleeding and the perforation in the literature.Based on the available information, detailed information of the subject device was not provided.Whereas, omsc assumes that the perforation was related to the subject device due to endoscopic resection of the submucosal layer.Therefore, omsc will submit one medical device report (mdr) as the event type for the 4 cases of the perforation.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE 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: 10655445
• Report Number: 8010047-2020-07479
• Device Sequence Number: 19619488
• Product Code: FDS
• UDI-Device Identifier: 04953170037047
• UDI-Public: 04953170037047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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-221U-25
• 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: 09/14/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other