MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-15 for FREEDOM EVO-2 200 10641200 manufactured by Tecan Schweiz Ag.
[22144121]
An evo instrument operator reached with their hand into the instrument while in operation and the pick and place arm (pnp gripper) hit their hand pinning it to the inside of the safety shield resulting in a bruise. On the day of the event, the operator's hand was swollen and hurting. There were no cuts or broken skin and the operator did not seek first aid or medical treatment. The operator was a contract employee of the laboratory and informed laboratory staff 3 days later of the event. The laboratory reported to tecan the event on (b)(6). At that time, the operator indicated the swelling had extended to the arm. Lab staff advised operator to consult a physician. No further information has become available about the nature or extent of the injuries or treatment required. Tecan made multiple attempts to obtain this information. The operator's injury was the result of disabled door locks which allowed the operator to reach inside a running instrument.
Patient Sequence No: 1, Text Type: D, B5
[22335808]
A tecan field service engineer went to the laboratory to evaluate the instrument. The door locks were disabled allowing for employees to reach into the instrument while in operation. Tecan installs instrumentation with door locks enabled. Additionally, tecan operator's manuals and warning labels on instrument caution operators to not reach into a running instrument as injury is possible. After investigation, it is unclear when or who disabled the door locks. The tecan service engineer enabled the door locks. The tecan service engineer enabled door locks and instrument passed applicable diagnostic testing. No evidence of malfunction was observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2013-00004 |
| MDR Report Key | 3232296 |
| Report Source | 05 |
| Date Received | 2013-07-15 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-06-24 |
| Date Mfgr Received | 2013-06-24 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-07-23 |
| 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 Contact | MR ALEXANDER KRIEG |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 119228560 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 200 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-07-15 |
| Model Number | EVO-2 200 |
| Catalog Number | 10641200 |
| 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 AG |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-15 |