MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-02 for LEICA RM2255 manufactured by Leica Biosystems Gmbh.
[2353217]
Customer sustained an injury to his finger while using the microtome. He was cut by the microtome blade. The customer went to the emergency room at hospital and required stitches.
Patient Sequence No: 1, Text Type: D, B5
[9377480]
The investigation revealed the following: since the hand wheel was not locked and no knife guard was mounted when removing the specimen block, the knife holder slipped down, when activated the foot pedal, and thus injured the finger as a result of a user error. In the instruction for use is written that the handwheel has to be locked and user shall cover the knife edge with the knife guard, when removing the specimen block.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2011-00010 |
| MDR Report Key | 2329876 |
| Report Source | 05 |
| Date Received | 2011-11-02 |
| Date of Report | 2011-10-07 |
| Date of Event | 2011-09-30 |
| Date Mfgr Received | 2011-10-07 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2011-11-10 |
| 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 | STEFFEN LAABS |
| 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 RM2255 |
| Generic Name | MICROTOME |
| Product Code | IDL |
| Date Received | 2011-11-02 |
| Model Number | RM2255 |
| 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 GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17-19 NUSSLOCH 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-02 |