MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-24 for FINE TRACTION DEVICE manufactured by Steris Corporation - Montgomery.
[20987861]
The user facility reported that during a patient procedure the fine traction adjustment wheel separated from the device. A steris account manager was present for the procedure and assisted the facility in utilizing a second fine traction unit which was staged nearby. The surgery was successfully completed without further incident. No injuries were reported in association with the event. A procedural delay was reported due to the exchange of the fine traction device.
Patient Sequence No: 1, Text Type: D, B5
[21308375]
The fine traction device has been sent to montgomery manufacturing for evaluation. The investigation of this event is currently in process. A follow-up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[30285624]
The fine traction device was returned to montgomery manufacturing for evaluation. The evaluation shows that excessive force was applied by the user to the crank handle of the fine traction device which caused damage to the device. Steris has confirmed that this is an isolated event. The facility was able to utilize a second fine traction device which was staged nearby and the surgery was successfully completed without further incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2013-00079 |
| MDR Report Key | 3245686 |
| Report Source | 06 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-07-24 |
| Date of Event | 2013-06-27 |
| Date Mfgr Received | 2013-06-27 |
| Date Added to Maude | 2013-10-21 |
| 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 |
| 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 | FINE TRACTION DEVICE |
| Generic Name | TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2013-07-24 |
| 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 | 2013-07-24 |