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

Model Number	UES-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shock (2072)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced unit was not returned to the manufacturer for evaluation.The biomed at the user facility further reported the staff only brought him the referenced unit.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.The cause of the reported event cannot be determined at this time.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.The instruction manual for the unit provides warning which states, before each case, inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument.Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.Confirm that the connections of the power cord, foot switch, patient plate, a cord, hand piece, adapter, bipolar electrode, bipolar cord and saline cord are secure and correct.To prevent electric shock, the ues-40 is designed to function with insulated connectors that have type cf applied parts (a cord, hand piece, patient plate).Therefore, to prevent shock caused by leakage current from other electrical equipment applied to the patient, the connectors should not be grounded.
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.

• 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: 8842241
• Report Number: 8010047-2019-02749
• Device Sequence Number: 285608
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• 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