MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-31 for TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5010 manufactured by Sakura Finetek Usa, Inc..
[41648695]
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. The auto section instrument is equipped with a red colored blade guard as a safety device to protect the user from accidental exposure to the blade edge and injury when used properly. Based on the information provided by the user facility, the user had received adequate training, however, failed to: verify the calibration status on the screen, and bring the blade guard up to its position when removing the block from the chuck which would have prevented this cutting injury. The operating manual, 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
[41648696]
Sakura received a complaint that user cut her finger while performing a microtome blade calibration with the tissue-tek autosection (r) instrument, product code 5010, ser# (b)(4). On the date of the event, (b)(6) 2016, a user was setting up her station after lunch to continue working, preparing to cut gi blocks and was performing a blade calibration using a new blade. She was looking at her computer screen while doing the calibration. She heard a 'click' sound and thought the unit completed calibration but did not verify the blade calibration status with the auto section screen. She then reached for a block but did not use the blade guard to cover the cutting edge while manipulating the block. The chuck dropped behind the blade holder to do the second alignment and cut her finger. She went to (b)(6) medical center (er), received stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2016-00001 |
| MDR Report Key | 5538274 |
| Date Received | 2016-03-31 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-03-16 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2016-03-31 |
| 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 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 AUTOSECTION(R) AUTOMATED MICROTOME |
| Generic Name | AUTOSECTION |
| Product Code | IDO |
| Date Received | 2016-03-31 |
| 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 214TJ STREET TORRANCE CA 90501 US 90501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-31 |