MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for SURE LOC XPS ARM POSITIONER manufactured by Steris Corporation - Montgomery.
[42872506]
The facility stated that on multiple occasions, the unit was positioned, and minutes later, the positioner dropped approximately once inch. A steris service technician arrived at the facility, inspected the unit, and identified the trigger pin did not seem fully engaged in the unit's locking mechanism. This would cause the unit to slip to the next locking position as reported by the facility. The unit was removed from service and returned to the 3rd party manufacturer for further evaluation. A replacement unit has since been provided to the user facility; no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[42872507]
The facility reported that the sure loc arm positioner did not operate to specification during a patient procedure. No injury, procedural delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2016-00036 |
| MDR Report Key | 5563998 |
| Date Received | 2016-04-08 |
| Date of Report | 2016-04-08 |
| Date of Event | 2016-03-14 |
| Date Mfgr Received | 2016-03-14 |
| Date Added to Maude | 2016-04-08 |
| 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 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 | 0 |
| Brand Name | SURE LOC XPS ARM POSITIONER |
| Generic Name | TABLE ACCESSORY |
| Product Code | FSE |
| Date Received | 2016-04-08 |
| 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 | 2016-04-08 |