MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK AUTOTEC® A120 AUTOMATED EMBEDDING SYSTEM; AUTOTEC A120

Model Number	7090
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 a customer reported to sakura field technical support (fts) agent that a cassette came out of the tissue-tek autotec a120 instrument without a lid which caused a tissue loss.Because it appeared the lid was off prior to the cassette getting to actual embedding, the instrument didn't error for a loose lid.Due to the tissue loss, a patient will have to undergo a re-biopsy.
Additional Manufacturer Narrative
Sakura field technical support (fts) confirms the unit was functioning as intended.This is a user issue of not assembling the paraform cassettes as instructed.While on the a120 being embedded, if the lid is not closed correctly, it can possibly catch on the cassette above it and cause the lid to come open when the gripper grabs it and pulls it out.But when it scans the cassette, it should recognize that the lid isn't closed correctly and reject the cassette.No corrective action required on the instrument because tissue-tek autotec a120 did not malfunction and is working within specification.The customer operating the instrument did not properly close the cassette lids causing the tissue loss in the instrument.Corrective action for the customer is to always have a trained professional user working on the instrument and properly close cassette lids prior to loading on the instrument.

• 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 387-0 023; JA 387-0023
• Manufacturer (Section G): SAKURA SEIKI CO., LTD.; nagano yawata shop1122-8; yawata; chikuma city, nagano 387-0 023; JA 387-0023
• Manufacturer Contact: takashi furuya ; nagano yawata shop1122-8; yawata; chikuma city, nagano 387-0-023 ; JA 387-0023
• MDR Report Key: 17981196
• Report Number: 2083544-2023-00007
• Device Sequence Number: 2491659
• Product Code: IEO
• UDI-Device Identifier: 04946433600362
• UDI-Public: 04946433600362
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: 7090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Congenital Anomaly; Other
• Patient Sex: Unknown