MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-23 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch Gmbh.
[26589941]
On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems field service engineer (fse) was notified by a user that earlier in the summer, she cut the end of her finger off while using the leica rm2255. Per the user, the injury occurred on (b)(6) 2015. The user was treated for her injury at (b)(6) and they were able to reattach the end of her finger. This incident was not initially reported to leica biosystems but was reported to the hospital, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[37745779]
The leica manufacturer completed their investigation and found that this incident was presumably user related. While the users fingertip was in the cutting area, she activated the cutting process via 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 sent out with recommendation in future to follow the description provided in the instruction for use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2015-00018 |
| MDR Report Key | 5099168 |
| Date Received | 2015-09-23 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-07-07 |
| Date Facility Aware | 2015-08-24 |
| Report Date | 2016-01-29 |
| Date Reported to FDA | 2016-01-29 |
| Date Reported to Mfgr | 2016-01-29 |
| Date Added to Maude | 2015-09-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2255 |
| Generic Name | ROTARY MICROTOME, |
| Product Code | IDO |
| Date Received | 2015-09-23 |
| Model Number | 1492255UL01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | 17-19 HEIDELBERGERSTR. NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-23 |