MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM 7019 manufactured by Sakura Finetek Usa, Inc..
[80432888]
The foam is inserted in the cassette as a convenience for the lab technicians. Due to the nature of the foam, the foam may detach from the cassette lid. As such sakura had added a warning label to each box as an additional safety factor to further warn the user to ensure the foam is in place before use. Furthermore, it is required by the operating manual, and training provided to the technicians to place the tissue on the foam in order to ensure the presence of the foam. Technicians are aware of this as this information is present in the instructions for use and it is also a subject during required hands on training.
Patient Sequence No: 1, Text Type: N, H10
[80432889]
On (b)(6) 2017, sakura finetek usa, inc. Was notified that a user site in the (b)(6) reported an incident which occurred on (b)(6)2016 and involved sakura's paraform 13x13 cassette. Site stated that one gastric biopsy containing 3 fragments, all 2 mm, was lost during processing and no tissue was made available for histological examination because the lab technician did not verify presence of the foam inside the cassette during embedding process. Furthermore, the lab technician failed to follow the instruction of placing tissue on the foam, as described in the instructions for use. The endoscopic report was issued, stated that the tissue was lost during processing, therefore, no histological assessment could be made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2017-00001 |
| MDR Report Key | 6718985 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-05-25 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2016-06-14 |
| Date Added to Maude | 2017-07-17 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SOLMAZ SHAIDA |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 3109727800 |
| Manufacturer G1 | SAKURA FINETEK USA, INC. |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM |
| Generic Name | BIOPSY CASSETTE |
| Product Code | IDZ |
| Date Received | 2017-07-17 |
| Catalog Number | 7019 |
| Lot Number | PM16165D03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAKURA FINETEK USA, INC. |
| Manufacturer Address | 1750 WEST 214TH STREET TORRANCE CA 90501 US 90501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-17 |