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

Model Number	SD-221L-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 october 7, 2020, olympus medical systems corp.(omsc) received literature titled "how to manage perforation related to endoscopic resection of superficial cancer".This study was reported endoscopic mucosal resection (emr) of a 5mm large lesion of the esophagus used the subject device.In the literature, it was reported that interoperative perforation has occurred.The mucosal resection was implemented with the subject device, and the defect of the muscular section was confirmed.The perforation was managed by applying endoscopic clipping.After surgery, fasting and antibacterial treatment were performed, and the patient was discharged on the 8th day.There are no descriptions of device relevance for all adverse events in the literature.There is no description of the device's malfunction.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 occurred during the procedure.Therefore, omsc will submit a medical device report (mdr) for 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: 10769893
• Report Number: 8010047-2020-08426
• Device Sequence Number: 3799348
• Product Code: FDS
• UDI-Device Identifier: 04953170326356
• UDI-Public: 04953170326356
• 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): 11/02/2020

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-221L-25
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/02/2020
• 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