MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-09 for LEICA RM2235 1492235EUUL manufactured by Leica Biosystems Nussloch Gmbh.
[30833431]
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
[30833432]
On (b)(6) 2015, leica biosystems received a complaint that a customer got an injury to his index finger and middle finger during the usage of the microtome. Medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[33606242]
The investigation revealed the following: the incident was user related. During the usage of the microtome the user grabbed to a tool which was stored next to the microtome device. Whilst this action the users jacket came to the knife protector of the device and pushed the blade guard downwards. While returning back to the work position the user grasped into the blade of the knifo holder with his left hand, causing lacerations of the index and middle fingers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2015-00007 |
| MDR Report Key | 5212156 |
| Report Source | OTHER |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-12 |
| Date Mfgr Received | 2015-10-13 |
| Device Manufacturer Date | 2015-01-30 |
| Date Added to Maude | 2015-11-09 |
| 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 | MR. 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 RM2235 |
| Generic Name | MICROTOME |
| Product Code | IDO |
| Date Received | 2015-11-09 |
| Model Number | 1492235EUUL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-09 |