MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[53438353]
On (b)(6) 2016 while installing a new microtome rm2255 at a customer site, a leica biosystems employee cut his finger on the instrument blade. The employee was unaware the customer had inserted a blade into the instrument blade holder. During the installation the instrument blade holder moved and caused the cut. Medical treatment was necessary to treat the cut. The incident was user related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2016-00009 |
| MDR Report Key | 5912431 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-08-10 |
| Date Facility Aware | 2016-08-10 |
| Report Date | 2016-08-29 |
| Date Reported to FDA | 2016-08-29 |
| Date Reported to Mfgr | 2016-08-29 |
| Date Added to Maude | 2016-08-29 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2255 |
| Generic Name | MICROTOME |
| Product Code | IDO |
| Date Received | 2016-08-29 |
| Model Number | 1492255UL01 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-29 |