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

Model Number 5010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/03/2023

Event Type  Injury  

Event Description

Sakura finetek third party service provider was dispatched to a customer site on 7/12/2023 to perform the preventive maintenance on tissue-tek autosection serial# (b)(6).The customer informed them that approximately 3-4 months ago, while working with the blade holder of tissue-tek autosection, the microtome activated and the head dropped, resulting in customer receiving 5 stitches on thumb.The incident occurred on (b)(6) 2023 but was reported to sakura finetek on 07/13/2023 by the third party service provider.The customer did not consider reporting this to sakura at the time and continued using the instrument without further incident and no cause was determined of how this happened.

Manufacturer Narrative

During the pm by third party service provider, the only issue encountered is the touchscreen often registers each touch twice.It is unknown if this could result in the head moving if accidentally brushed against, but did not find any other issues with the unit.

• 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, CA 90501 ; 3109727800
• MDR Report Key: 17390475
• MDR Text Key: 319768224
• Report Number: 2083544-2023-00004
• Device Sequence Number: 1
• Product Code: IDO
• UDI-Device Identifier: 00615233079350
• UDI-Public: 00615233079350
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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