MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-24 for EVO-2 200 MCA 30020020 manufactured by Tecan Schweiz.
[4443061]
A laboratory employee reported an 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 and d purposes. The laboratory stated that the door locks had 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
[11776114]
The laboratory contacted tecan by email on (b)(4) 2014 for a copy of the instrument operator's manual stating that an injury had occurred. Upon phone follow up, the laboratory indicated that an employee was injured while reaching into the instrument as it was running to switch out a plate. The employee's hand was stab by a tip. There was no additional information on the extent of injuries; however, medical attention was sought. The door locks were disabled by placing tape over the door lock mechanism. The laboratory indicated that the instrument door locks had been disabled for a long time possibly back to install. Tecan's labeling warns against accessing the instrument while in operation and the door locks are designed to prevent access without pausing the instrument. The laboratory re-engaged door locks and sent an internal safety alert to ensure all other instruments were checked for proper guarding.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2014-00002 |
| MDR Report Key | 3784287 |
| Report Source | 05 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-03-28 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-05-02 |
| 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 | TECAN SCHWEIZ |
| 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 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 | DA |
| Device Eval'ed by Mfgr | N |
| 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 |