MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number	UES-40
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a physician could not remove a polyp during a procedure while using a ues-40 electrosurgical unit.The user facility used their ues-40 surgmaster electrosurgical unit with unnamed 3rd party snares.The reporter said that the physician was unable to remove the polyp as the snares only made it halfway to three quarters of the way through the polyp.The physician believed the problem resided with the generator and not the snares.The generator did not display an error code and it seemed to have its normal audible tone while in use.The patient went to the hospital two days later and had the polyp removed, without problems.The reporter also said that they have been using the electrosurgical unit since the event without any problems.The snares were disposed and not sent to the original manufacturer for evaluation.

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8963261
• Report Number: 2951238-2019-01103
• Device Sequence Number: 2609313
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2019
• Report Date (Section F): 09/04/2019

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: UES-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2019
• 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
• Date Report Sent to FDA: 09/04/2019