MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-03 for OT 1200 TABLE manufactured by Steris Corporation - Montgomery.
[21947888]
Investigation remains in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[22193361]
The user facility reported that the table was not operating properly during a patient procedure. No injuries to staff or patients have been reported. It is unknown if procedural delays or cancellations have occurred.
Patient Sequence No: 1, Text Type: D, B5
[30285720]
Steris attempted to obtain additional patient information however the user facility declined. A steris service technician arrived at the facility, inspected the table and replaced both of the fine traction devices. The fine traction devices were returned to steris montgomery for evaluation. The evaluation determined that the operator of the fine traction device had exceeded the range of the unit's adjustment wheel. Steris has confirmed this is an isolated event, however will continue to monitor any reports related to the issue described. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00100 |
| MDR Report Key | 3383904 |
| Report Source | 06 |
| Date Received | 2013-10-03 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-09-03 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2014-01-08 |
| 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 |
| 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 | OT 1200 TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2013-10-03 |
| 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 | 2013-10-03 |