MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-04-29 for TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5000 manufactured by Sakura Finetek Usa, Inc..
[143538741]
Sakura investigation identified that the cause as user error. Customer stated that the user started a trim then decided she didn't want it, pressed the trim button multiple times to stop it. However, pressing the trim button again after a trim has been started will not immediately stop the current operation, it will stop it at the end of the current trim cycle. Examination of the log file shows that the trim button was pressed six times before the emergency stop button was pressed. Customer stated that the trim button was pressed to stop the movement of the blade. Based on the investigation and customer feedback, it was concluded that the user was trimming the tissue blocks routinely, replaced the trimmed tissue blocks with new samples and cut her thumb as she reached for the block while the autosection was still moving. To immediately stop the operation, the emergency stop button should have been pressed. From this examination it was determined that the cause of the incident was operator error, pressing a wrong button in attempt to stop the instrument. A maintenance check was performed on april 8th and 9th, 2019 of the subject instrument. No indication of malfunction was identified. Customer was still using the instrument in their daily routine work at that time; however, the instrument was taken out of commission following an internal safety review on april 11, 2019. 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 autosection instrument is equipped with a red colored blade guard and audio/visual alert as a safety device to protect the user from accidental exposure to the blade edge and injury when used properly. The operating manual of the autosection, sec 1. 4. 1 warnings and 4. 6 routine operation - warnings, 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143538742]
Sakura was informed about a user cut injury on (b)(6) 2018, in (b)(6), with the autosection, ser# (b)(4). User accidentally cut about 10 mm of tip of the thumb and required plastic surgery to reattach it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2019-00001 |
| MDR Report Key | 8563064 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2019-04-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Remedial Action | OT |
| 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 | 2019-04-29 |
| Catalog Number | 5000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-29 |