MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-19 for LEICA CV5030 149CVTS5025 manufactured by Leica Biosystems Nussloch Gmbh.
[45473267]
An investigation of the incident is currently ongoing. A follow up including the outcome of the investigation will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[45473268]
On (b)(6) 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. Patient identifier information was also requested from the customer but to date, the (b)(6) did not want to provide this information.
Patient Sequence No: 1, Text Type: D, B5
[47508027]
The investigation revealed the following: the incident was possibly related due to a short temporary impairment of the output rack elevator. The field service engineer could not be replicated the issue at customer site. The filed service engineer aligned the output rack elevator via service software, cleaned the instrument and performed a test run to verify the operation without further issues. The test run passed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2016-00002 |
| MDR Report Key | 5665881 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-19 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-04-20 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2008-07-04 |
| Date Added to Maude | 2016-05-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT GROPP |
| Manufacturer Street | HEIDELBERGERSTR. 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal | 69226 |
| Manufacturer Phone | 6224143345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CV5030 |
| Generic Name | COVERSLIPPER, PRODUCT CODE: KIM |
| Product Code | KIM |
| Date Received | 2016-05-19 |
| Model Number | 149CVTS5025 |
| 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 STRASSE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-19 |