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

Model Number 5010

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

This is a user error by sakura employee.Employee did not follow the instruction as per operating manual and did not ensure the blade guard was in place before removing the cassette.

Event Description

Sakura finetek was notified of an incident on (b)(6) 2022 which occurred on (b)(6) 2022 with the autosection instrument, serial no.(b)(4).Incident occurred during installation of instrument.While setting up the autosection instrument, sakura field application specialist noticed the blocks that the client used were bigger than the normal cassettes used; therefore, sakura employee put one of the client's cassette in the unit to ensure it would clear the blade holder.Employee pressed the align button and realized he did not want to cut into the client's block, so the employee tried to grab the cassette before the unit started.The unit started and brought employee's finger on the blade causing a deep cut across the tip of employee's left thumb.

• 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 st; torrance CA 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501 ; 3109727800
• MDR Report Key: 14988015
• MDR Text Key: 295719131
• Report Number: 2083544-2022-00001
• 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: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 5010
• Device Catalogue Number: 5010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention