MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-27 for LEICA CM1950 1491950C5EU manufactured by Leica Biosystems Nussloch Gmbh.
[78460037]
An investigation of the incident is currently underway and a follow up will be submitted, if additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[78460038]
On (b)(6) 2017, the customer reported a damaged tissue after cutting on their leica cm1950. As a result, the tissue could not be diagnosed and one patient is confirmed to require rebiopsy.
Patient Sequence No: 1, Text Type: D, B5
[113560293]
The investigation revealed the following: the logs of the affected instrument were analyzed and no technical issues were detected with the microtome component of the (b)(4) instrument. The issue could not be replicated. A preventive maintenance was performed. Additionally cutting tests were performed with the user to verify the operation without further issues. The cutting tests passed. The conclusion is that this was a single case event and the affected customer site is fully functional following a preventive maintenance. No further actions are required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2017-00005 |
| MDR Report Key | 6669318 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-27 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2008-09-04 |
| Date Added to Maude | 2017-06-27 |
| 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 CM1950 |
| Generic Name | CM1950 |
| Product Code | IDP |
| Date Received | 2017-06-27 |
| Model Number | 1491950C5EU |
| 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 | 2017-06-27 |