MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-15 for LEICA CV5030 14047839700 manufactured by Leica Biosystems Nussloch Gmbh.
[4979525]
The customer reported that one slide was destroyed during the coverslipping process. Consequently, the specimen was damaged and could not be diagnosed. As a result, a new 'pap smear' of one pt was necessary.
Patient Sequence No: 1, Text Type: D, B5
[12476359]
An investigation of the incident is currently underway and a follow up will be submitted should add'l info become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2014-00012 |
| MDR Report Key | 4202113 |
| Report Source | 05 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-08-20 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-08-21 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Postal | 69226 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CV5030 |
| Generic Name | COVERSLIPPER |
| Product Code | KIM |
| Date Received | 2014-09-15 |
| Model Number | CV5030 |
| Catalog Number | 14047839700 |
| 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 NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STR. 17-19 NUSSLOCH 69226 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-15 |