MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-02 for LEICA CM1520 149491520US manufactured by Leica Biosystems Nussloch Gmbh.
[61291479]
The investigation revealed the following: the field service engineer could not replicate the issue at the customer site. The incident was possibly user related due to an incorrectly implemented application method of preparing the tissue for cutting on the instrument. The method which the customer used was to "flash freeze" the specimen with liquid nitrogen. The "flash freeze" method means the tissue was submerged into liquid nitrogen and then frozen onto the sample plate for cutting on the device. Depending on the size of the tissue and the length of time in the liquid nitrogen, the tissue can become very hard and cold. If the tissue samples are then cut with high trimming and quick turns of the instrument handwheel, pieces of the frozen tissue can chunk off the sample plate and fall into the cryostat chamber. In most cases the samples are not lost; the tissue must be re-frozen and the patient would not have to be biopsied again. Unfortunately, in this case a re-biopsy was necessary because an incorrectly implemented application method was used.
Patient Sequence No: 1, Text Type: N, H10
[61291480]
On 08 november 2016, leica biosystems received a user facility medwatch form 3500a from the fda regarding a necessary re-biopsy of one patient. The customer complaint was that the device was chunking into the tissue block during cutting. Upon receipt of this user facility medwatch form 3500a, leica biosystems initially became aware that a re-biopsy was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010478-2016-00006 |
| MDR Report Key | 6140636 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-02 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-08-03 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2016-12-02 |
| 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 | 9622414334 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA CM1520 |
| Generic Name | CRYOSTAT |
| Product Code | IDP |
| Date Received | 2016-12-02 |
| Model Number | 149491520US |
| Device Availability | Y |
| 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 | 2016-12-02 |