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 Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On april 7, 2025, when the incident was reported to sakura finetek usa, the reporter (b)(6) added that following the incident, the tissue-tek vip 6 ai unit was shut down and sequestered in anticipation of inspection by sakura finetek usa.No additional incidents were reported after the unit was taken out of service.(b)(6) confirmed that the tissue processing had followed the protocol outlined in the operating manual.No error codes were displayed during the run, and reagents were verified as correctly loaded using both smell and physical appearance.Tissues that were less severely affected during the incident were subsequently reprocessed on a different unit and yielded diagnostic results.On april 17, 2025, sakura finetek usa dispatched a service technician to inspect the tissue-tek vip® 6 ai vacuum infiltration processor (115 vac, 50/60 hz, 12 a), which had not been in use since the reported incident.The technician noted multiple "low fluid" errors associated with stations 7 and 8 of the unit.During the inspection, the technician tested fluid movement between stations and checked for leaks but found no malfunctions.The device was determined to be operating within the manufacturer's specifications.A definitive cause for the affected tissue could not be identified during the inspection.However, potential contributing factors may include user error, such as not following the reagent handling instructions outlined in the operating manual or failing to maintain appropriate reagent levels in the device.
Event or Problem Description
On april 7, 2025, (b)(6) notified sakura finetek usa technical services (ts) of an incident that occurred on (b)(6) 2025, involving the tissue-tek vip 6 ai vacuum infiltration processor (115 vac, 50/60 hz, 12 a).On the day of the incident, the unit processed 140 tissue samples- a mix of fatty and large autopsy tissues- which appeared to be either over-processed or under-processed.(b)(6) reported that, in some cases, the nuclei were completely obliterated, giving the tissue the appearance of autolyzed or "cooked" autopsy tissue.All cassettes from that processing run were affected to varying degrees, though only four cases were deemed undiagnosable: three breast tissue cases and one colon case with lymph nodes.According to (b)(6), these four cases were signed out as undiagnosable due to processing errors and artifacts that rendered the tissue slides unreadable.Sakura finetek usa received further details regarding the individual cases at a later date due to hipaa restrictions.The reported cases were summarized as follows: case 1: colon cancer- staging could not be determined.Case 2: mastectomy with a prior diagnosis of dcis- unable to confirm the presence of invasive cancer.Case 3: lumpectomy with sentinel lymph node and additional margins- margin status and lymph node involvement could not be confirmed; accurate t-stage could not be determined.Case 4: breast needle biopsy- no definitive diagnosis possible; re-biopsy was recommended.The remaining cases from the affected run were successfully diagnosed after reprocessing on a different unit.

• 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: 22187929
• Report Number: 2083544-2025-00006
• Device Sequence Number: 15542716
• Product Code: IEO
• UDI-Device Identifier: 04946433600539
• UDI-Public: 04946433600539
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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