MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-04-14 for TISSUE-TEK UNI CASSETTE 4119-01 manufactured by Sakura Finetek Usa, Inc..
[16734012]
Anatomic pathology tissue cassette lid closed incompletely or loosened during tissue processing. The defective cassettes were not detected immediately through the normal quality control procedures.
Patient Sequence No: 1, Text Type: D, B5
[16931748]
Review and evaluate processing and quality control procedures of the cassette manufacturer to ensure adequate quality control levels for in-process inspection of cassettes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083544-2010-00002 |
| MDR Report Key | 1668370 |
| Report Source | 08 |
| Date Received | 2010-04-14 |
| Date of Report | 2010-03-24 |
| Date of Event | 2010-02-26 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2010-12-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 8009727800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE-TEK UNI CASSETTE |
| Generic Name | UNI-CASSETTE |
| Product Code | IDZ |
| Date Received | 2010-04-14 |
| Catalog Number | 4119-01 |
| Lot Number | 433673 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAKURA FINETEK USA, INC. |
| Manufacturer Address | TORRANCE CA 90501 US 90501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-14 |