MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2013-05-29 for FINE TRACTION DEVICE manufactured by Steris Corporation.
[45228030]
The steris fine traction device was sent back to montgomery manufacturing for evaluation where it was determined that an incorrect part was used during the assembly of the accessory. Steris corporation has initiated a voluntary field correction ((b)(4)) on all affected fine traction devices.
Patient Sequence No: 1, Text Type: N, H10
[45228031]
The user facility reported that while a patient was being setup, the tracking assembly system would not rotate. The patient was transferred to another table and the case was completed successfully. No injuries to hospital staff or patients were reported. A procedural delay was reported due to the transfer of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2013-00050 |
| MDR Report Key | 5650288 |
| Report Source | USER FACILITY |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-29 |
| Date of Event | 2013-04-29 |
| Date Mfgr Received | 2013-04-29 |
| Date Added to Maude | 2016-05-12 |
| 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 G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK 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 | FINE TRACTION DEVICE |
| Product Code | JEB |
| Date Received | 2013-05-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-29 |