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 CV5030 manufactured by Leica Biosystems Gmbh.
[2512626]
Customer reported that the coverslips were not positioned correctly on the slides. Consequently, the tissue was damaged because the slides and coverslips break down into the device and were split. Therefore the tissue were not diagnosable, but a rebiopsy was not necessary.
Patient Sequence No: 1, Text Type: D, B5
[9623185]
The unit was evaluated by leica service technician. The analysis indicated the cause for the malfunction was due to the misaligned gripper position. Thereby the slide detecting was not working properly. After the gripper position and slide detecting was readjusted, the service technician conducted a test run which confirmed the proper functioning of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2011-00013 |
| MDR Report Key | 2437486 |
| Report Source | 05 |
| Date Received | 2011-12-27 |
| Date of Report | 2011-11-24 |
| Date of Event | 2011-11-24 |
| Date Mfgr Received | 2011-11-24 |
| Device Manufacturer Date | 2008-12-01 |
| 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 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 CV5030 |
| Generic Name | COVERSLIPPER |
| Product Code | KIM |
| Date Received | 2011-12-27 |
| Model Number | CV5030 |
| 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 | 2011-12-27 |