MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-19 for ORTHOVISION SURGICAL TABLE ACCESSORY manufactured by Steris Corporation - Montgomery.
[3263747]
The user facility reported that prior to the start of a procedure, the feet of a patient were being secured into the foot traction boots. When traction was applied to the left boot, the patient's foot slipped out of the boot.
Patient Sequence No: 1, Text Type: D, B5
[10731206]
A steris field service technician inspected the tenzor carbon fiber traction unit assembly used in the procedure. This is an accessory used in conjunction with the steris orthovision surgical table. The technician found no defects during his evaluation, but contacted the steris account manager for assistance in identifying any issues. A steris account manager examined photographs of the padded boot and discovered this is not the standard boot currently supplied with the tenzor carbon fiber traction unit assembly. It is a previous version of the tenzor boot, used with an older version of the traction unit assembly. It appeared that at least one of the velcro straps was not in place on the boot for support. The customer was provided information on different accessory boots that may provide more robust restraint. The customer was also provided an in-service on proper usage of padded traction boots in conjunction with the carbon fiber traction unit assembly. The steris orthovision operator's manual states: "warning - personal injury and/or equipment damage hazard: check the table orthopedic extension abductor bars, siderails and carbon fiber traction unit for possible damage or wear prior to each use. Do not use the carbon fiber traction unit if any damage is apparent, if parts are missing or if it does not operate as expected".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00036 |
| MDR Report Key | 3068580 |
| Report Source | 06 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-19 |
| Date of Event | 2013-03-20 |
| Date Mfgr Received | 2013-03-20 |
| Date Added to Maude | 2013-06-24 |
| 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 LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| 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 SURGICAL TABLE ACCESSORY |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2013-04-19 |
| 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 | 2013-04-19 |