MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for VIVIDIMAGE T 26IN SURGICAL MONITOR manufactured by Steris Corporation - Vts Medical Systems.
[55887053]
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.
Patient Sequence No: 1, Text Type: N, H10
[55887054]
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.
Patient Sequence No: 1, Text Type: D, B5
[62413898]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000404456-2016-00008 |
| MDR Report Key | 5974050 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-09-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION - VTS MEDICAL SYSTEMS |
| Manufacturer Street | 40 MELVILLE PARK RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVIDIMAGE T 26IN SURGICAL MONITOR |
| Generic Name | SURGICAL MONITOR |
| Product Code | KQM |
| Date Received | 2016-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - VTS MEDICAL SYSTEMS |
| Manufacturer Address | 40 MELVILLE PARK RD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-23 |