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

Model Number UES-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 152696274
• Report Number: 2951238-2019-01028
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Distributor Facility Aware Date: 07/02/2019
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PATIENT PLATE: MAKE/MODEL/SERIAL UNKNOWN
• Patient Outcome(s): Other