MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-16 for TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5010 manufactured by Sakura Finetek Usa, Inc..
[54992296]
Microtome blades are extremely sharp and inherently dangerous. Inattention to the task at hand and failure to utilize safety devices can cause a serious injury. During calibration the autosection makes a 'click' sound when the chuck pauses between steps. Users are always trained the same way by a field technical support: all safety instructions, symbols, precautions and features; always use the blade guard when manipulating a block; after a blade calibration, users are instructed to read the screen; it reads "blade calibration complete" and calibration number is displayed. It is suspected that two things occurred: user failed to look at the screen to determine if the blade calibration was completed; she did not bring the red colored blade guard up when removing the block from the chuck. The operating manual of the autosection, sec 1. 4. 1 and 4. 6, clearly states that user must "always lock the hand wheel and cover the cutting edge with the blade guard prior to manipulating the blade or the specimen, changing the specimen, or when the instrument is not in use. " the instrument did not malfunction or cause this injury; it functioned as intended according to the specifications and is safe to use.
Patient Sequence No: 1, Text Type: N, H10
[54992297]
Sakura was notified on september 1, 2016, that user cut her finger while calibrating the tissue-tek autosection(r) instrument, product code 5010, ser# (b)(4), using a new blade. During calibration, she heard a 'click' sound and thought the unit completed calibration. She reached for the block and the chuck went down behind the blade holder to do the second alignment and stopped with her thumb and finger in-between the blade holder and chuck. She hit the emergency stop button. Another technician pushed up on the chuck holder and was able to raise it slightly up so she could twist her fingers out. She sought medical attention and received 6 stitches to her thumb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2016-00003 |
| MDR Report Key | 5958036 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-01 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2016-09-16 |
| 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 | 3 |
| Brand Name | TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME |
| Generic Name | AUTOSECTION |
| Product Code | IDO |
| Date Received | 2016-09-16 |
| Catalog Number | 5010 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2016-09-16 |