MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-09 for LEICA CV5030 manufactured by Leica Biosystems Gmbh.
[3080114]
Customer reported that the slide broke during the coverslipping process. Consequently, the tissue was damaged because the slides were completely destroyed. Therefore the tissue was not diagnosable, and the pt had to be reexamined to collect another cytology smear small biopsy.
Patient Sequence No: 1, Text Type: D, B5
[10272312]
The unit was evaluated by leica service technician. The analysis indicated the cause for the malfunction was due to the misaligned gripper position. Furthermore the slider movement was not working properly. After the gripper position and slider movement was readjusted, the service technician conducted a test run which confirmed the proper functioning of the device. A design change request was initiated and the investigation work is still continuing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2012-00005 |
| MDR Report Key | 2834947 |
| Report Source | 05 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-15 |
| Date of Event | 2012-09-28 |
| Date Mfgr Received | 2012-10-15 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2013-02-15 |
| 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 | ROBERT GROPP |
| 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 CV5030 |
| Generic Name | COVERSLIPPER |
| Product Code | KIM |
| Date Received | 2012-11-09 |
| Model Number | CV5030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS GMBH |
| Manufacturer Address | HEIDELBERGERSTR. 17-19 NUSSLOCH 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-09 |