MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-08 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[94223035]
The investigation revealed the following: this incident is user related because the user disregarded the safety instructions. The customer forgot to engage the lock and did not use the safety cover for the blade. The injury was not an instrument malfunction. A safety training was performed with the customer to avoid this injury in future.
Patient Sequence No: 1, Text Type: N, H10
[94223036]
On (b)(6) 2017, leica biosystems received a complaint that a customer injured his finger during the usage of the microtome. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2017-00008 |
| MDR Report Key | 7099263 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-08 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-11-13 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2017-12-08 |
| 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 | MR. ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| 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 | 2017-12-08 |
| 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 | 2017-12-08 |