MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for LEICA CV5030 149CVTS5025 manufactured by Leica Biosystems Nussloch Gmbh.
[45150820]
On april 22, 2016 leica biosystems received a complaint that a user's finger was cut while retrieving broken glass slides from inside the unit. Stitches were required to close the cut. The manufacturer is currently still investigating this incident and a follow up report will be submitted once this is complete. Patient identifier information was also requested from the customer but to date, the lab manager did not want to provide this information. If this or additional information is received, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[47409631]
Following the investigation by the leica manufacturer, the conclusion is that the incident was possibly related to a temporary impairment of the instrument output rack elevator. The issue could not be replicated on-site by the leica field service engineer. The leica engineer aligned the instrument output rack elevator, cleaned the instrument and performed a test run to verify the operation without further issue. The test run passed. On (b)(6) 2016, leica biosystems received information that the injured lab technician was a female in her 50's. No other specific patient identifier information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2016-00003 |
| MDR Report Key | 5653709 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-04-20 |
| Date Facility Aware | 2016-04-22 |
| Report Date | 2016-06-14 |
| Date Reported to FDA | 2016-06-14 |
| Date Reported to Mfgr | 2016-06-14 |
| Date Added to Maude | 2016-05-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CV5030 |
| Generic Name | COVERSLIPPER |
| Product Code | KIM |
| Date Received | 2016-05-13 |
| Model Number | 149CVTS5025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-13 |