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

Model Number	5010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2083544-2023-00004
• Device Sequence Number: 8913583
• Product Code: IDO
• UDI-Device Identifier: 00615233079350
• UDI-Public: 00615233079350
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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 Model Number: 5010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown