MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-13 for ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[20751175]
The user facility reported that during a patient procedure an employee was moving the patient's leg and the foot stirrup clamp moved causing the patients left foot to drop. The user facility readjusted and tightened the foot stirrup and completed the procedure successfully.
Patient Sequence No: 1, Text Type: D, B5
[20959125]
A steris surgical service representative inspected the table and found it to be operating properly; no issues were noted. The technician was only able to duplicate the reported event when the vertical boot harness clamp was not properly tightened as it was in the reported event. When he tightened it properly and applied downward force to the boot harness, no movement occurred. The table was placed back into service and no further issues have been reported. The operator manual states, "warning-personal injury hazard: when installing any table accessory, check for correct attachment and tighten securely (if appropriate). Do not use worn or damaged accessory. Check installation before using any accessory. " while onsite the technician discussed with user facility personnel that the clamp was not properly tightened which caused the reported event to occur. The table is not under steris service contract and is serviced and maintained by the facility's biomedical department.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2014-00071 |
| MDR Report Key | 4006601 |
| Report Source | 06 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-13 |
| Date of Event | 2014-07-14 |
| Date Mfgr Received | 2014-07-14 |
| Date Added to Maude | 2014-08-13 |
| 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 | 2014-08-13 |
| 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 | 1. Other | 2014-08-13 |