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

Catalog Number 5010

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problems Not Applicable (3189); Missing Value Reason (3192)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• 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: 5958036
• MDR Text Key: 54992296
• Report Number: 2083544-2016-00003
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Catalogue Number: 5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• 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