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

Catalog Number 5000

Device Problem Device Handling Problem (3265)

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

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Local sakura representatives were on site on monday 10 june 2019.Based on the input received from the customer the emergency stop button and the performance of the footpedal were checked.Both operated as intended, where the emergency stop button immediately stopped the movement of the chuck and the foot pedal stopped the operation after finishing the section.The functionality of the instrument was also assessed; no abnormalities were found during the operation of the autosection unit.A log file analysis was performed by sakura finetek europe technical support as well as technical service from sakura finetek usa.No abnormalities were found during the operation of the autosection unit.According to the received data from the instrument, the system operated properly.Information provided by the local application specialist is that the red blade guard for the microtome blade is not utilized by the laboratory as this is viewed as impractical.The user was operating (the remote of) the unit with her right hand and kept her left hand near the chuck.This is routine as the tissue ribbon needs to be guided by the user.The logfiles suggest that standard routine for the laboratory is to use the align/face protocol and decreasing the trim speed after initial trimming.Looking at the information provided by the user and the logfiles, it is clear that the instrument did not record any press of the button to stop before the 106 consecutive trimming cycles.After this activity, the first log entry is from the test performed by the local field safety engineer.The user stated to have pressed the emergency stop button to stop the movement of the chuck, pointing towards 2 possible events: the user pressed the section button after 106 trimming movements.Pressing any of the buttons to stop sectioning will result in the autosection to finish the current movement.As the trimming speed was set to the minimum speed level, the movement of the chuck is slow and the user may have thought that she could get the tissue block.The user thought she pressed a button to stop the trimming movement but did not press the button in reality, or the emergency button was not pressed fully to disable the movement of the chuck.Due to the low speed of the chuck, the user mistakenly thought it safe to get the tissue block.The autosection instrument is equipped with a red colored blade guard and audio/visual alert as safety precautions to protect the user from accidental exposure to the blade edge and injury when used properly.This means the safety lighting will change color (from red to white) and a click will be audible indicating the chuck is into place and stopped.Based on the above sakura finetek europe considers the incident to be user related (failure to adhere to safety measures).The laboratory has taken the instrument in use again.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).

Event Description

On 07 june 2019 sakura finetek europe (b)(4) received communication from the local sakura business manager detailing a serious accident at (b)(6).The end user cut herself while using the instrument in autotrim mode.According to the initial information, the user stated she was doing the sectioning, stopped the instrument by touching one of the buttons and then moved her hand to take out the tissue block.In that specific time, the chuck went down forcing her finger onto the microtome blade.The end user and a colleague nearby tried to stop the instrument by pressing the foot pedal, which seemed to be unresponsive.

• 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: 8745155
• MDR Text Key: 149647935
• Report Number: 2083544-2019-00002
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• 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