MAUDE Adverse Event Report: STERIS CORPORATION - VTS MEDICAL SYSTEMS VIVIDIMAGE T 26IN SURGICAL MONITOR

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A karl storz camera was being utilized during the time of the reported event.The image from the camera was being displayed on the steris vivid image monitor during the patient procedure.A steris service technician inspected the monitor and found a compatibility issue between the karl storz camera and steris vivid image monitor.Steris is working with the user facility to resolve the reported event.Investigation of this event is currently in process.

Event Description

The user facility reported that during a patient procedure the image displayed on the monitor froze.A procedural delay occurred due to the reported event.No report of injury.

Manufacturer Narrative

A steris service technician inspected the steris vividimage monitor and system and made repairs so the monitor properly displayed the image from the (b)(6) camera.The steris technician tested the system and (b)(6) camera and confirmed them to be operating properly.No additional compatibility issues have been reported.

• Brand Name: VIVIDIMAGE T 26IN SURGICAL MONITOR
• Type of Device: SURGICAL MONITOR
• Manufacturer (Section D): STERIS CORPORATION - VTS MEDICAL SYSTEMS; 40 melville park rd; melville NY 11747
• Manufacturer (Section G): STERIS CORPORATION - VTS MEDICAL SYSTEMS; 40 melville park rd; melville NY 11747
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5974050
• MDR Text Key: 55887053
• Report Number: 1000404456-2016-00008
• Device Sequence Number: 1
• Product Code: KQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1