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

Model Number	UES-40
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that during an unspecified procedure, the biomed at the user facility reported that when using the unit, a patient experienced a shock at the grounding pad.There was no information if there was any additional harm done to the patient due to being shocked.Additionally, the biomed indicated that the patient plate was expired and that the unit was set to 10watt of power in cut mode.The staff only brought the referenced unit for testing and the biomed noted that he could not determine the cause of the reported "patient was shocked at the patient plate" as there was no patient plate to test with the unit.The unit was tested and the outputs of the unit were within the required range.

• 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: 8842403
• Report Number: 2951238-2019-01028
• Device Sequence Number: 289917
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/30/2019
• Report Date (Section F): 07/30/2019

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: 07/02/2019
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT PLATE: MAKE/MODEL/SERIAL UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/30/2019