MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-03 for LEICA RM2235 1492235EUUL manufactured by Leica Biosystems Nussloch Gmbh.
[18086727]
On (b)(6) 2015, leica biosystems received a complaint that a customer got an injury to her left thumb during the usage of the microtome. Med treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[18461814]
The investigation revealed the following: this incident is presumably user related because the user did not lock the handwheel, per the user manual revision. The locking mechanism has been checked by a leica service engineer. The instrument is operating within spec. A customer facing letter will be send to the customer with recommendation in future to follow the description provided in the instruction for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2015-00001 |
| MDR Report Key | 4567331 |
| Report Source | 05 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-02-23 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2015-03-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT GROPP |
| Manufacturer Street | HEIDELBERGER STR. 17-19 |
| Manufacturer City | NUSSLOCH 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 224143345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2235 |
| Generic Name | NONE |
| Product Code | IDO |
| Date Received | 2015-03-03 |
| Model Number | 1492235EUUL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STR. 17-19 NUSSLOCH 69226 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-03 |