MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-20 for LEICA CM1950 1491950C2EU manufactured by Leica Biosystems Nussloch Gmbh.
[49950481]
The investigation revealed this incident was user related. The instrument knife holder was inadequately maintained causing the instrument handwheel to become sluggish. While cleaning the knife holder in the chamber of the cryostat, the internal technician did not properly use the blade guard and thus cut his finger. A customer facing letter will be sent out with recommendation in the future to follow the maintenance and safety instructions provided in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[49950482]
An internal technician of a clinical center cut his finger while cleaning the leica cm1950. Stitches were required to close the cut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2016-00004 |
| MDR Report Key | 5808049 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-20 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-17 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2015-03-06 |
| Date Added to Maude | 2016-07-20 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 | 6224143345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1950 |
| Generic Name | CM1950 |
| Product Code | IDP |
| Date Received | 2016-07-20 |
| Model Number | 1491950C2EU |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | GMBH HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-20 |