MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK VIP6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ

Model Number 6032

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Distress (2329)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

Sakura finetek europe (sfe) measured the samples of reagents provided from the site and identified that the formalin values were extremely low; they ranged from 1.6 to 1.8 where it should be 3.8 - 4.2.The low formalin level typically causes tissue fixation issues, and artefacts in the tissues known as "parched earth." xylene, which should have clear appearance, was found to be discolored, it had yellow to orange appearance, which suggested a reagent swap or improper cleaning or maintenance of the containers.Alcohol levels were found to be adequate.Sfe technical support engineering reviewed the log files for the applicable run which finished on (b)(6) 2019, as customer also reported error code 915 during the applicable runs.The error code 915 is displayed when the retort lit was opened causing the processing to stop.User stated that in between tissue processing and a cleaning run they removed the tissues from the retort.The error code 915 was then displayed when the retort lid was opened to take out the tissue and alert the user to confirm that the tissue was removed from the retort.The activation of error code 915, thus, was considered adequate and occurred per design.The engineer also noticed that there were 3 other sensor related errors in the log from (b)(6) 2019, thus, checked the level sensors and found that they were not clean.User confirmed that they hadn't cleaned the sensors, nor performed warm water flush in the last 2.5 months.No device issue was identified.Based on all information gathered, it became evident that the instrument was not in an optimal condition and required maintenance/service.A recommendation was made to user that a full preventive maintenance and re-training of users be performed.Another visit by the field service engineer has been scheduled to follow up with user on january 22, 2020.

Event Description

It was reported to sakura finetek europe on december 30, 2019, of an incident at the customer's site which occurred on (b)(6) 2019, in (b)(6) using the tissue-tek vip6 instrument, serial number (b)(4).It stated that the tissues were observed with poor quality after a processing run.They replaced a reagent (alcohol 70% in station 3) and attempted to process the tissue samples, and obtained the same results.The affected tissue samples had a dry "parched earth" appearance with cracks.The instrument also displayed error code 915 (the retort lid was opened causing the processing to stop).Out of hundred sixty (160) affected tissue samples, five (5) required to be re-biopsy in order to be diagnosable.

• Brand Name: TISSUE-TEK VIP6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ
• Type of Device: VIP6
• Manufacturer (Section D): SAKURA SEIKI CO., LTD.; 75-5, imojiya; chikuma, 387-0 015; JA 387-0015
• Manufacturer (Section G): SAKURA SEIKI CO., LTD.; 75-5, imojiya; chikuma, 387-0 015; JA 387-0015
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance 90501 ; 3109727800
• MDR Report Key: 9618521
• MDR Text Key: 189638285
• Report Number: 2083544-2020-00001
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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