MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-27 for LEICA RM2235 manufactured by Leica Biosystems Gmbh.
[2556860]
Customer reported that while cutting with the microtome, the hand grip of the hand wheel of the rotary microtome came loose from the bolt on which the hand grip is mounted.
Patient Sequence No: 1, Text Type: D, B5
[9593691]
The investigation indicated the cause for the malfunction was due to the incorrect functioning of the handwheel handle. The hand grip which were mounted on a bolt were not properly held, because of not enough glue between the bold and hand grip was applied. The handwheel was completer replaced, anda performance test was conducted to ensure that the device was working properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2011-00012 |
| MDR Report Key | 2437477 |
| Report Source | 05 |
| Date Received | 2011-12-27 |
| Date of Report | 2011-11-23 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-23 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-07-26 |
| 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 | STEFFAN LAABS |
| Manufacturer Street | HEIDELBERGER STR. 17-19 |
| Manufacturer City | NUSSLOCH 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 224143345 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2235 |
| Generic Name | MICROTOME |
| Product Code | IDO |
| Date Received | 2011-12-27 |
| Model Number | RM2235 |
| 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 | HEIDELBERGER STR. 17-19 NUSSLOCH 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-27 |