MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-04-24 for EVO-2 200 MCA 30020020 manufactured by Tecan Schweiz.
[4379888]
A laboratory employee was injured while operating the freedom evo instrument. The door locks were disabled and the operator reached into the instrument during operation. The operator's finger was punctured and the operator did receive medical treatment. The extent of treatment or the seriousness of the injury was not shared with tecan. The instrument was being used for r&d purposes. The laboratory stated that the door locks has been disabled for a long time and he did not know who disabled them. The laboratory sent a copy of their internal safety report to tecan indicating the door locks were re-engaged and prohibiting intentionally disabling equipment guards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037985-2014-00002 |
| MDR Report Key | 3783536 |
| Report Source | 99 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-03-28 |
| Date Facility Aware | 2014-03-28 |
| Report Date | 2014-04-23 |
| Date Reported to FDA | 2014-04-23 |
| Date Reported to Mfgr | 2014-03-28 |
| Date Added to Maude | 2014-05-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVO-2 200 MCA |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-04-24 |
| Catalog Number | 30020020 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ |
| Manufacturer Address | MAENNEDORF, ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-24 |