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

Catalog Number 5010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 03/15/2016

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.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.

Event Description

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.

• Brand Name: TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME
• Type of Device: AUTOSECTION
• Manufacturer (Section D): SAKURA FINETEK USA, INC.; 1750 west 214tj 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, CA 90501 ; 3109727800
• MDR Report Key: 5538274
• MDR Text Key: 41648695
• Report Number: 2083544-2016-00001
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 03/31/2016
• 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