MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK VIP 6 AI, 230VAC

Model Number 6042

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Sakura finetek usa was notified by sakura finetek europe on april 25,2024 that a local service engineer visited the customer on 19-mar-2024 to collect the instruments logfiles, reagent samples and to check and clean the instrument.An obstruction was found in the connector of station number 4 of the instrument which was then removed.After this, the customer did not report any issues with the use of the instrument.Logfiles were analysed by technical support and found no technical defects in vacuum, pressure, temperatures.Instrument performed according to technical specifications.Logfiles and reagents samples of the run in question were analysed by application support.It was found that the customer isn't performing the weekly warm water flushes according to the recommended cleaning procedures as stated by the manufacturer in the operating manual of the device.Not performing warm water flushes on a regular base, increases the of buildup of formalin crystals and eventually blockage of tubing.This is the most likely rootcause of the issue that the customer experienced.Reagent samples were measured and found to be of the correct values, nothing out of specification was observed.Sakura finetek europe has not received any information on patient impact by the time of this report.

Event Description

Sakura finetek europe notified sakuta finetek usa on 28-mar-2024 about the incident that occured on (b)(6) 2024, the customer experienced an issue with the tissue-tek vip 6 ai on 12-mar-2024 where the instrument stopped processing at station 4 (alcohol).They had contacted a sakura employee who talked them through the issue and they were able completed the run without impact on tissue.After this run, the customer performed a cleaning with water and acetic acid.A new run was initiated and started in the night from 13th on 14th of march without testing the instrument and the issue reoccurred.This time, the samples were hard to cut and impact on patient has not yet been communicated to sakura finetek europe.

• Brand Name: TISSUE-TEK VIP 6 AI, 230VAC
• Type of Device: VIP 6 AI
• 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: 19202485
• MDR Text Key: 341277457
• Report Number: 2083544-2024-00003
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6042
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other