MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-25 for ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[4621879]
The user facility reported that during a patient procedure their orthovision table did not rise in height all the way. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[12147130]
A steris service technician arrived at the facility, inspected the table and confirmed the table was operable. The technician checked the hydraulic fluid level of the table and inspected the hydraulic system for leaks. The technician confirmed the table to be operational and returned it to service. Steris offered in-service training on the proper use and operation of the table to the user facility and is awaiting a response.
Patient Sequence No: 1, Text Type: N, H10
[23137806]
Steris' offer of in-service training was declined by the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2014-00062 |
| MDR Report Key | 3958101 |
| Report Source | 06 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-06-21 |
| Date Mfgr Received | 2014-06-25 |
| Date Added to Maude | 2014-07-25 |
| 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 | 0 |
| Event Location | 0 |
| 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 - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOVISION TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2014-07-25 |
| 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 - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-25 |