MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for TISSUE-TEK(R) CRYO3(R) FLEX, 115 V BASIC, MOHS 6209 manufactured by Sakura Finetek Usa, Inc..
[99770624]
Microtome blades are extremely sharp and inherently dangerous. Inattention to the task at hand and failure to follow the procedure can cause a serious injury. The operating manual has a warning in section 1 to alert users to be careful when handling exposed blade.
Patient Sequence No: 1, Text Type: N, H10
[99770625]
Sakura was notified on (b)(4) 2018, that user cut her finger and had to get stitches. User was having trouble placing a knife into the holder, says it was because of the excess frost buildup on the blade holder. When placing the blade she was not able to get it in the whole way. She was in a hurry, so she began cutting with a large portion of the blade exposed. During sectioning her hand slipped and her finger was cut. She had to go to the emergency room and get stitches the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2018-00003 |
| MDR Report Key | 7262144 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-02-09 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SOLMAZ SHAIDA |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE 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) CRYO3(R) FLEX, 115 V BASIC, MOHS |
| Generic Name | CRYO3 FLEX MOHS |
| Product Code | IDO |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2018-02-15 |
| Catalog Number | 6209 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-09 |