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

Model Number 5000

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

Patient Problem Laceration(s) (1946)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

The technician was trained in april 2021 on operating the autosection, and worked with the instrument almost daily and is considered very experienced.The customer was instructed to stop usage of the instrument until sakura inspected the instrument.A sakura technical engineer visited the customer on (b)(6) 2023 and conducted a technical and visual inspection, but no abnormalities were found.The sakura application specialist visited the customer on (b)(6) 2023 to test the instrument and concluded that the autosection worked as intended within specification.Preliminary analysis of the autosection log files from the moment of incident do not show any abnormalities with the operation of the autosection.

Event Description

Sakura finetek europe was notified of an incident on (b)(6) 2022, which occurred in (b)(6) on (b)(6) 2022 with the tissue-tek autosection automated microtome instrument, ser#: (b)(4).A (b)(6) customer reported a technician was injured by their autosection ivd device, and asked for technical inspection of the instrument.The customer reported that the technician used the foot pedal to stop the autosection from operation (this is intended behavior).According to the technician, the instrument stopped operation (slicing motions to cut tissue in a cassette) and wanted to remove the cassette, but during this act, the instrument started to move again without user interaction and the incident happened.The fingertip of the technician was severed and placed back with surgery after visiting the emergency room of the hospital.

• 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: 16139182
• MDR Text Key: 307105021
• Report Number: 2083544-2023-00001
• Device Sequence Number: 1
• Product Code: IDO
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other