MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-15 for LEICA RM2155 manufactured by Leica Biosystems Gmbh.
[2200470]
Customer sustained an injury to his right index finger tip while using the microtome. He was cut by the microtome blade. The customer went to the emergency room at hospital. Stitches were not required, only a bandage was necessary.
Patient Sequence No: 1, Text Type: D, B5
[9470903]
The investigation revealed the following: the microtomes safety guard was broken the day before, so presumably the lab temporary employee could not identify the defective knife holder, and had been cut on the right index finger. The knife holder with the knife guard was complete replaced, and a performance test was conducted to ensure that the device was working properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2011-00008 |
| MDR Report Key | 2259092 |
| Report Source | 05 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-08-17 |
| Date Mfgr Received | 2011-08-25 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2011-09-23 |
| 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 Postal | 69226 |
| Manufacturer Phone | 224143345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2155 |
| Generic Name | MICROTOME |
| Product Code | IDL |
| Date Received | 2011-09-15 |
| Model Number | RM2155 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-15 |