MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for CRYOSTAT manufactured by Leica Biosystems Richmond.
[58380254]
Patient Sequence No: 1, Text Type: N, H10
[58380255]
While cutting patient tissue the cryostat began "chunking out" or cutting too deeply and too quickly into the specimen, thereby leaving the tissue unreadable and not viable. The provider was immediately notified and the "troubleshooting" steps at the operator level were performed. These steps were deemed not helpful in rectifying the problem, again the provider was notified and leica, the manufacturer was notified. Leica arrived on site and substantiated, that indeed the machine was not performing correctly and was giving inconsistent results and began "troubleshooting" at the manufacturer level. After several failed attempts to correct the machine, it was determined that a new head was to be installed in the machine the next day and that a "loaner" machine would be sent overnight for the next business day. Unfortunately, during the machine malfunction, the patient's specimen was damaged and not able to be interpreted. This required additional tissue to be taken and sent for permanent section. Manufacturer response for cryostat, (brand not provided) (per site reporter): refer to description of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6056770 |
| MDR Report Key | 6056770 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-03 |
| Report Date | 2016-09-23 |
| Date Reported to FDA | 2016-09-23 |
| Date Reported to Mfgr | 2016-09-23 |
| Date Added to Maude | 2016-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | CRYOSTAT |
| Generic Name | MICROTOME, CRYOSTAT |
| Product Code | IDL |
| Date Received | 2016-10-26 |
| Lot Number | 1510S-3 |
| ID Number | 347302 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 US HIGHWAY 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-26 |