MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-02 for GROSS TRACTION UNIT manufactured by Steris Corporation - Montgomery.
[19730889]
The user facility reported that during a patient procedure, the gross traction unit did not operate properly. A steris account manger was present at the time of the event and assisted the staff in exchanging the gross traction unit with a backup unit and the case was completed successfully. A procedural delay was reported due to the exchange of the gross traction unit.
Patient Sequence No: 1, Text Type: D, B5
[19820169]
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
[33266545]
The steris account manager provided pictures of the gross traction unit which shows what appear to be fractures along both sides of the unit. This source of the damage could not be confirmed, but it likely resulted from impact damage. The unit subject of this event was returned to steris for evaluation. The evaluation determined the only cause of the malfunction could have been the damage to the locking mechanism.
Patient Sequence No: 1, Text Type: N, H10
[33266546]
No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2013-00127 |
| MDR Report Key | 3494713 |
| Report Source | 06 |
| Date Received | 2013-12-02 |
| Date of Report | 2013-12-02 |
| Date of Event | 2013-11-08 |
| Date Mfgr Received | 2013-11-08 |
| Date Added to Maude | 2014-03-11 |
| 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 | GROSS TRACTION UNIT |
| Generic Name | TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2013-12-02 |
| 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 | 2013-12-02 |