MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-18 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[65025174]
The investigation revealed the following: this incident is presumably user related because the user did disregard the safety instructions. The customer did not wear gloves during the usage of the instrument in the manual mode as described in the instruction for use. A customer facing letter will be sent to the customer with a recommendation in the future to follow the description provided in the instruction for use.
Patient Sequence No: 1, Text Type: N, H10
[65025175]
On (b)(6) 2016, leica biosystems received a complaint that a customer injured her finger during usage of the microtome. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2017-00001 |
| MDR Report Key | 6259451 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-18 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2010-06-22 |
| Date Added to Maude | 2017-01-18 |
| 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 |
| 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 |
| Product Code | IDO |
| Date Received | 2017-01-18 |
| 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, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-18 |