MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-30 for LEICA RM2125 manufactured by Leica Biosystems, Gmbh..
[2347428]
Customer reported that while cutting with the microtome, the universal cassette clamp did not hold the blocks tightly. The tissue samples were pulled out from the embedding material, however, they were not destroyed and could be further processed and were able to be diagnosed.
Patient Sequence No: 1, Text Type: D, B5
[9354827]
The investigation indicated the cause for the malfunction was due to the incorrect functioning of the universal cassette clamp. The cassettes which were used were not properly held by the clamp. The analysis of the affected clamp has been shown that one of the two springs is broken. Thereby a stable terminal of the clamp is no longer possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2011-00009 |
| MDR Report Key | 2281602 |
| Report Source | 05 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-08 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-08 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2012-06-28 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA RM2125 |
| Generic Name | MICROTOME |
| Product Code | IDL |
| Date Received | 2011-09-30 |
| Model Number | RM2125 |
| 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 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |