MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-22 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[26393239]
An investigation of the incident is currently ongoing and a follow up including the outcome of the investigation will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[26393240]
On (b)(6) 2015, the customer reported an injury using a rotary microtome. The user was treated for her injury at (b)(6) and they were able to reattach the end of her finger.
Patient Sequence No: 1, Text Type: D, B5
[32284732]
This incident was presumably user related. While the users fingertip was in the cutting area, she activated the cutting process by the foot pedal. Safety gloves were not worn, as described in the instruction for use: "when working with microtomes, personal safety precautions must always be taken. It is mandatory to wear work safety shoes, safety gloves, a mask and safety goggles. " a customer facing letter will be send out with recommendation in future to follow the description provided in the instruction for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2015-00006 |
| MDR Report Key | 5093857 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-22 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-08-24 |
| Device Manufacturer Date | 2005-12-16 |
| Date Added to Maude | 2015-09-22 |
| 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 | ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 6224143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2255 |
| Generic Name | MICROTOM |
| Product Code | IDO |
| Date Received | 2015-09-22 |
| Model Number | 1492255UL01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-22 |