MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK® VIP®6,FLOOR TISSUE PROCESSOR,115V,60HZ; VIP 6

Model Number 6030

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Sakura finetek usa was first reported of this incident on (b)(6) 2024 by dr.(b)(6) where he described the incident and added that when he attempted to read the slide no-nuclei detail was found and the tissue was pale all across under the scope.It was also confirmed that unit in question is used as large specimens unit.In his previous communications, it was also confirmed that the tissues processed on the time of the event were breast/ other small and large tissues mixed on the same processing run.Dr (b)(6) also did not have information on how often the reagents were changed or if the users of the device had followed the expected routine for reagent change for the most efficient results.Dr.(b)(6) also confirmed that since the incident ((b)(6) 2024), the customer have been running the unit and the tissues have looked great without tissue processing issue.Between the time the incident occured ((b)(6) 2024) and the incident was reported to sakura finetek usa, our third part service provider- mattern biomedical services had sent their technician to trouble shoot the processing issue around (b)(6) 2024.The service technician sent his report to the sakura finetek's customer service on april 17th reported that no issue was observed related to the adverse event and the device was functioning as intended.After the repair tech was onsite the customer dumped all reagents and there is nothing available for further testing for validation of the contents or reagents percentage of contamination.All downloaded reports show the unit used another station for a low reagent at a station that was low.This is what the unit is supposed to do with the solution manager they had selected on the unit.On 28-march-2024, sakura finetek's technical services has also sent out a detailed information on how to operate the device most efficiently for intended results.Sakura finetek usa is unable to receive further information on the incident from the customer's (b)(6) representative as suggested by the initial reporter dr.(b)(6) after his last conversation on 29-march-2024.Sakura finetek usa does not have enough information to pinpoint the root cause for the affected under- processed tissue, but there is a possibility of reagents not sufficiently and timely replaced by the customer that could have contributed to the occurence of this adverse event.There is no further information on the patient that underwent re-biopsy and any further health impact.

Event Description

Sakura finetek usa was informed on march 26th by its customer (b)(6) regarding the incident that occurred on (b)(6) 2024 due to 6 underprocessed tissues that were not diagnosable.The tissues would not adhere to the slide during sectioning and during the attempt to read the tissues, it was observed by dr.Boone of st.Jude medical center that no nuclei was observed and the tissue was pale all across under the scope.1 patient underwent rebiopsy for breast core tissue as the processed tissue was not diagnosable.

• Brand Name: TISSUE-TEK® VIP®6,FLOOR TISSUE PROCESSOR,115V,60HZ
• Type of Device: VIP 6
• 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: 19209049
• MDR Text Key: 341355069
• Report Number: 2083544-2024-00004
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/08/2024

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: 6030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2013
• 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