MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for ORTHO VISION SURGICAL TABLE manufactured by Steris Corporation - Montgomery.
[75666444]
During the time of the reported event, the table top was level and the patient was secured to the table with restraints and coban tape. User facility personnel heard a "pop" sound as the patient's torso began to shift to the left side of the table. The patient was repositioned on the table and the procedure was completed successfully as no delays or cancellations were reported. A steris service technician arrived onsite to inspect the ortho vision table and found the table to be operating per specifications. The technician confirmed there was no evidence of any hydraulic leaks and did not note any issues with the operation of the table's tilt and lateral translations. The ortho vision table is not under a steris service contract and is maintained by a third-party service provider. In-service training was scheduled for 4/25/2017 however the user facility requested that steris reschedule. Steris account manager has made multiple attempts to reschedule in-service training on the proper use and maintenance of the table with the facility and the facility has not responded.
Patient Sequence No: 1, Text Type: N, H10
[75666445]
The user facility reported that during a patient procedure, they heard a "popping" noise and the ortho vision table moved without being commanded to do so. The patient did not sustain any injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2017-00030 |
| MDR Report Key | 6576993 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-18 |
| 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 | ORTHO VISION SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2017-05-18 |
| 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 | 2017-05-18 |