MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-23 for EVO-2 200 10641202 manufactured by Tecan Schweiz.
[4589137]
A laboratory employee was injured reaching into the freedom evo 200 instrument while instrument was running on (b)(6) 2014. The event was reported to tecan on (b)(6) 2014 with a request to re-engage the door locks. The employee received a puncture to his finger from the fixed tip dispensing needles on the liquid handling arm. The finger bled and employee was initially treated by a corporate nurse. An internal safety incident was filed. No add'l info regarding treatment or the seriousness of injury was shared with tecan. The instrument was processing pt samples at the time of the incident. The door locks were disabled on the instrument.
Patient Sequence No: 1, Text Type: D, B5
[11973683]
A tecan fse was on site on (b)(4) 2014 at laboratory for an unrelated issue and was informed that a lab employee was injured by the evo 200 robot's liquid handling arm when reaching into the instrument during operation. The instrument operator's finger was punctured by the fixed tip dispensing needles on the liquid handling arm. The laboratory was running pt samples at the time of the incident potentially resulting in biohazard exposure to the wound area. The door locks on the instrument were disabled allowing for the operator to reach in without having to pause the instrument. The door locks had been previously disabled. Tecan's labeling warns against accessing the instrument while in operation and the door locks are designed to prohibit access without pausing the instrument. A tecan field service engineer was dispatched to reconnect the door locks and test instrument to ensure it passed all safety tests.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2014-00001 |
| MDR Report Key | 3866641 |
| Report Source | 05 |
| Date Received | 2014-04-23 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-03-28 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2014-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 449228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVO-2 200 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-04-23 |
| Catalog Number | 10641202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-23 |