MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for LEICA RM 2255 manufactured by Leica Biosystems.
[63495274]
Patient Sequence No: 1, Text Type: N, H10
[63495275]
Histology tech was cutting slides when she noticed the smell of smoke, she and other co-workers confirmed the device was smoking. The device was turned off. Manufacturer response for histo microtome, leica (per site reporter): manufacture alerted and a loaner unit was sent in. Service tech will set up loaner device this afternoon. We are waiting on additional information from the manufacture at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6212157 |
| MDR Report Key | 6212157 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-12-02 |
| Report Date | 2016-12-05 |
| Date Reported to FDA | 2016-12-05 |
| Date Reported to Mfgr | 2016-12-05 |
| Date Added to Maude | 2016-12-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | MICROTOME, ACCESSORIES |
| Product Code | IDO |
| Date Received | 2016-12-29 |
| Model Number | RM 2255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS |
| Manufacturer Address | 5205 ROUTE 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |