MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-11-19 for FREEDOM EVO-2 200 MCA 30020020 manufactured by Tecan Schweiz.
[3963895]
Laboratory called tecan on (b)(6) to report that during a test run of an evo 200 mca liquid handling pipettor instrument, the operator had pressed the pause button and reached inside the instrument to remove tips that were stuck to the mca head. The pause button was lit indicating instrument was paused. While the operator's hand was inside the instrument, the mca head moved down pinning the operator's hand to the deck of the instrument. The operator hit the pause button to unpause the instrument and the mca head moved up freeing the operator's hand. The operator sustained minor injury to the hand including a cut with bleeding. No medical treatment was required other than basic first aid. The test run was without reagents and the tips were clean and sterile. No risk of biohazard exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037985-2013-00002 |
| MDR Report Key | 3504644 |
| Report Source | 99 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-11-15 |
| Date of Event | 2013-11-01 |
| Date Facility Aware | 2013-11-01 |
| Report Date | 2013-11-15 |
| Date Reported to FDA | 2013-11-18 |
| Date Reported to Mfgr | 2013-11-04 |
| Date Added to Maude | 2013-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4022 STIRRUP CREEK RD. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer G1 | TECAN U.S. |
| Manufacturer Street | 4022 STIRRUP CREEK RD. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 200 MCA |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-11-19 |
| Catalog Number | 30020020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| 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 | 2013-11-19 |