MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK VIP® 6 AI VACUUM INFILTRATION PROCESSOR; 115 VAC, 50/60 HZ, 12 A; VIP 6 AI

Model Number	6040
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Sakura finetek usa was notified by fda on 30-apr-2025 about the medical device report submitted via medwatch program.The email notification from fda included notification letter and the submitted medical device report for sakura finetek usa's awareness.The medical device report (form 3500a) was submitted by an anonymous customer for the event that took place in 19-mar-2025.In the report submitted to the fda, customer has described that a tissue processing issue was identified, affecting a subset of pathology cases leading to tissue processing/fixation issues.Several tissue samples were affected; however, three cases remained suboptimal for reading which affected patient care.These cases either require a change in treatment plan or a second procedure to obtain additional tissue samples.
Additional Manufacturer Narrative
The customer reporting the medical device report asked to remain confidential; therefore, sakura finetek usa is unable to contact the initial reporter to further investigate and determine the root cause of the reported issue.

• Brand Name: TISSUE-TEK VIP® 6 AI VACUUM INFILTRATION PROCESSOR; 115 VAC, 50/60 HZ, 12 A
• Common Device Name: 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: 22110442
• Report Number: 2083544-2025-00005
• Device Sequence Number: 6950854
• Product Code: IEO
• UDI-Device Identifier: 04946433600539
• UDI-Public: 04946433600539
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown