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 2018-07-10 for TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5000 manufactured by Sakura Finetek Usa, Inc..
[113623232]
Sakura investigation identified that the cause as software bug, user's not following the warning blinking lights and user's not using the blade guard. The autosection software returned the chuck to the home position when the estop button was released as stated in the autosection user manual, p/n 0006801-01 rev. J, sec 1. 5. 1 components and figures. However, after a few seconds, the chuck started moving, which was not intended by design. Two blinking warning red/white led lights indicate the chuck is in a paused state and will move soon. Refer to the user manual, sec 1. 4. 3 safety features. User failed to follow the visual warning and proceeded to place the block in the chuck. User manual also states in the sec 1. 4. 1 warnings to "always cover the cutting edge with the blade guard prior to manipulating the blade or the specimen, changing the specimen... " this was not followed. 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. Review of our complaint file indicated no complaint of estop malfunction since the launch of the autosection in 2012 to the receipt of this complaint on (b)(4) 2018, over (b)(4) manufactured units. The software bug had been internally identified and the fix was incorporated into the new software version (v5. 90) which was released in may 2018. The field implementation is to begin immediately. Updated instruments will be monitored to ensure effectiveness of the software changes. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[113623233]
Sakura was informed about a user cut injury on (b)(6) 2018, in the (b)(6), during a user training with the autosection, ser# (b)(4) (software version 5. 89). The initial investigation revealed that the emergency stop button (estop) did not perform as intended during the demonstration. The user continued with placing a block into the block holder while the safety lights were blinking and resulted in a minor finger cut injury. The wound was taped closed and wrapped with a compressed gauze. The estop button is a red-colored manual control device designed to stop all operations of the instrument when pressed. When it is released by a twist-to-release motion, the instrument should not cause a restart command. The blinking safety lights indicate that the block holder (chuck) is in a paused state and will move soon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2018-00005 |
| MDR Report Key | 7676109 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-07-10 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2018-07-10 |
| 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 | 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 | RP |
| 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 | 2018-07-10 |
| Catalog Number | 5000 |
| 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 | 2018-07-10 |