MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-24 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[52847139]
This incident was user related. While installing the object holder on new microtome rm2255 the leica biosystems employee didn't realize the customer had placed a blade in the blade holder. The blade holder moved and he cut his finger. He required stitches. The instructions for use includes the following safety instructions: "when working with microtomes, personal safety precautions must always be taken. It is mandatory to wear work safety shoes, safety gloves, a mask and safety goggles. Take care when handling microtome knives and disposable blades. The cutting edge is extremely sharp and can cause serious injuries! "
Patient Sequence No: 1, Text Type: N, H10
[52847140]
A leica biosystems employee was installing a new microtome rm2255 on customer site and caused a cutting damage on his finger. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2016-00005 |
| MDR Report Key | 5899674 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2016-05-21 |
| Date Added to Maude | 2016-08-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 9622414334 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2255 |
| Generic Name | MICROTOM, PRODUCT CODE: IDO |
| Product Code | IDO |
| Date Received | 2016-08-24 |
| Model Number | 1492255UL01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-08-24 |