MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-10 for CRYOSTAT CM 1850 * manufactured by Leica Microsystems.
[341362]
Fuse had blown so that motor that advances the tissue to blade did not function. There is no warning light or indicator to let you know that this occurred. Reporter was unable to cut frozen section when tissue arrived in lab. The event occurred more than a year ago. The surgeon was waiting on the results from the lab. Since the tissue could not be cut, they could not let the surgeon know anything. There is a back-up but it would have to have been coded to be used. Since the defective cryostat did not have an indicator for a blown fuse, they did not have the back-up device ready.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030491 |
| MDR Report Key | 502632 |
| Date Received | 2003-12-10 |
| Date of Report | 2003-09-01 |
| Date Added to Maude | 2003-12-29 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOSTAT |
| Generic Name | * |
| Product Code | IDP |
| Date Received | 2003-12-10 |
| Model Number | CM 1850 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 491399 |
| Manufacturer | LEICA MICROSYSTEMS |
| Manufacturer Address | 2345 WAUKEGAN ROAD BANNOCKBURN IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-10 |