MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Temperature Problem (3022)

Patient Problem Blister (4537)

Event Date 03/02/2022

Event Type  Injury  

Event Description

The customer reported during a procedure, the patient was burned by the olympus device through the drape and had a blister.The light source was attached to an unknown endoscope at the time of the injury.No additional information was provided.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13976372
• MDR Text Key: 288382788
• Report Number: 2951238-2022-00365
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/02/2022,04/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ENDOSCOPE
• Patient Outcome(s): Other