MAUDE Adverse Event Report: Sakura Seiki Co., Ltd. Tissue-Tek AutoTEC® a120 Automated Embedding System; AutoTEC a120

Model Number	77090
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Tissue-Tek AutoTEC® a120 Automated Embedding System
• Common Device Name: AutoTEC a120
• Manufacturer (Section D): Sakura Seiki Co., Ltd.; nagano yawata shop1122-8; yawata; chikuma city, nagano 987-0 023; JA 987-0023
• Manufacturer (Section G): Sakura Seiki Co., Ltd.; nagano yawata shop1122-8; yawata; chikuma city, nagano 987-0 023; JA 987-0023
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501
• MDR Report Key: 50873631
• Report Number: 2083544-2026-00003
• Device Sequence Number: 10661595
• Product Code: IEO
• UDI-Device Identifier: 04946433600362
• UDI-Public: 04946433600362
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 77090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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