MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for SCHURE LOC XPS ARM POSITIONER manufactured by Steris Corporation - Montgomery.
[59876704]
The user facility reported that their schure loc arm accessory to their surgical table was slipping out of the locked position during a patient procedure. No procedure delays or cancellations were reported. The schure loc arm is an interoperative limb positioner which provides the orthopedic team with a secure hold of their patient's extremities for shoulder surgeries. The schure loc arm is not manufactured by steris. The manufacturer of the schure loc arm was notified of the reported event. The schure loc arm subject of the reported event is being returned to the manufacturer for evaluation. The instructions for use states: warning! Risk of injury due to unintended movements downwards. When squeezing the trigger, the swivel joints are released and the schure loc xps can be moved. Due to its own weight and the weight of the patient it will fall downwards. Before squeezing the trigger, firmly hold the schure loc with both hands. After every adjustment process, ensure that the trigger is released and locks the schure loc into place. Check that no foreign bodies are pinched. The steris account manager will complete in-service training on the proper use and operation of the device once the facility receives a replacement product.
Patient Sequence No: 1, Text Type: N, H10
[59876766]
The user facility reported that their schure loc arm accessory was not operating properly during a patient procedure. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[60952892]
The schure loc arm accessory is not manufactured by steris corporation. This product is used as an accessory with a steris surgical table. Steris has provided schuerch corporation, the manufacturer of the schure loc arm accessory, with the information regarding the reported event. This follow up report is being sent as steris is the distributor of the schure loc arm accessory and user facility personnel contacted steris, not schuerch corporation, following the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2016-00088 |
| MDR Report Key | 6090787 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-08-15 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-11-09 |
| 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 | 3 |
| Brand Name | SCHURE LOC XPS ARM POSITIONER |
| Generic Name | TABLE ACCESSORY |
| Product Code | FSE |
| Date Received | 2016-11-09 |
| 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 | 2016-11-09 |