MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME

Catalog Number 5000

Device Problem Program or Algorithm Execution Failure (4036)

Patient Problems Injury (2348); Skin Tears (2516)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

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)].

Event Description

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.

• Brand Name: TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME
• Type of Device: AUTOSECTION
• Manufacturer (Section D): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• Manufacturer (Section G): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance 90501 ; 3109727800
• MDR Report Key: 7676109
• MDR Text Key: 113623232
• Report Number: 2083544-2018-00005
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other