MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for FOOT TRACTION BOOT TO ORTHOVISION TABLE manufactured by Steris Corporation - Montgomery.
[112188920]
Based on the description on the event, it appears that the foot traction boot was not properly secured causing the reported event. As the doctor began to push down on the patient's foot the foot traction boot detached from the table causing the doctor to lose his balance and the patient's leg to lower in height. A steris service technician arrived onsite to inspect the orthovision table. While onsite, the technician found that the foot traction boot was not attached to the surgical table. The technician inspected the table and found it to be operating according to specification; no repairs were required. A steris account manager offered in-service on the proper use and operation of the orthovision surgical table and the user facility has accepted this offer. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[112188921]
The user facility reported that during a patient procedure, the doctor began to push down on the foot traction boot attached to the othovision table when the boot came loose causing the doctor to fall backwards and the patient's leg to fall from the boot. No injuries to the doctor or patient were associated with the reported event. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00050 |
| MDR Report Key | 7627378 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-25 |
| Date Added to Maude | 2018-06-21 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| 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 | FOOT TRACTION BOOT TO ORTHOVISION TABLE |
| Generic Name | FOOT TRACTION BOOT TO ORTHOVISION TABLE |
| Product Code | JEB |
| Date Received | 2018-06-21 |
| 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 | 2018-06-21 |