MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-10 for ORTHOVISION SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[31096272]
A steris field service technician arrived onsite, inspected the surgical table, and was able to duplicate the reported event with weight on the table. When a table lowers as duplicated by the technician, it is indicative of a slight loss of hydraulic pressure. The technician inspected the hydraulic pump assembly and identified that the check valve required replacement. The technician replaced the check valve. The relief valve was also replaced as a precautionary measure. The table was tested, confirmed to be operating according to specification, and returned to service. No additional issues have been reported. A check valve allows for fluid to flow through it in a single direction and a relief valve is used to control or limit pressure in a system. If either of these valves required replacement, a loss in pressurization could occur and cause the event as reported. Section 1 of the operator manual for the orthovision surgical table states, "warning - failure hazard: the safe and reliable operation of this equipment requires regularly scheduled preventive maintenance in addition to the faithful performance of the minor maintenance described in this manual. " section 4: preventive maintenance of the maintenance manual for the orthovision surgical table states, "check hydraulic oil level [and] check table base, all hoses, fittings, and components of hydraulic system for evidence of oil leaks... 6 x per year. " the table is not under steris contract agreement for maintenance and this is the first time steris has serviced the surgical table. The user facility is responsible for the maintenance of the table. The technician has reviewed the preventive maintenance schedule of the orthovision surgical table with the user facility.
Patient Sequence No: 1, Text Type: N, H10
[31096273]
The user facility reported that their orthovision surgical table slightly lowered during a patient procedure. No report of injury or procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2015-00113 |
| MDR Report Key | 5215285 |
| Date Received | 2015-11-10 |
| Date of Report | 2015-11-10 |
| Date of Event | 2015-10-12 |
| Date Mfgr Received | 2015-10-12 |
| Date Added to Maude | 2015-11-10 |
| 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 - 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 | 0 |
| Brand Name | ORTHOVISION SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2015-11-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-11-10 |