MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-10 for ACUITY manufactured by Varian Medical Systems.
[19662271]
Varian was notified of an employee accident report. During the routine build of an acuity exact couch, the operator was assisting a fellow employee to remove a faulty actuator when the scissor mechanism collapsed and crushed the employee's hand. The employee was examined by a doctor for the injury and was off work for 10 days. No other info was provided in the report regarding the injury.
Patient Sequence No: 1, Text Type: D, B5
[19671361]
It was determined that the employee did not follow the standard operating procedures when replacing the faulty actuator. A safety brace was omitted during the process, which prevents the potential for collapse. The employee has been briefed on the absolute need for the use of safety braces when working within the scissor mechanism. Though still under investigation, varian has determined that an mdr is appropriate. Add'l f/u to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00008 |
| MDR Report Key | 1802655 |
| Report Source | 05,06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-05-26 |
| Date Added to Maude | 2012-03-14 |
| 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 | MICHAEL PIGNATARO |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 7029384800 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 9RG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SYSTEM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2010-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-10 |