MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK VIP® 6 VACUUM INFILTRATION PROCESSOR; VIP6

Model Number 6032

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

Per sakura finetek europe investigation, the technical engineer analyzed the retrieved log files of the instrument and did not find any deviations that could have caused the issue that the customer experienced.The only noticeable thing was that the reagent level in the retort of the instrument changes during the vacuum and pressure cycles.This can be the result of a leaking gate valve that is not sealing correctly.The local technical engineer visited the customer on 6-mar-2024.The instrument behaved according to specification and nothing unusual could be found.The gate valve was not leaking and there wasn't any damage to the instrument.Several tests were performed, and the unit showed correct results.As the customer did not notice the impact on tissue right away, subsequent runs were completed after the affected run and.No issues concerning diagnosis on these runs were reported to us.The application specialist could not take samples of the reagents used during the run in question as the customer had refreshed all containers (standard procedure of the lab to do so every friday).We are unable to investigate if the reagents contributed to the incident.The customer provided pictures of the affected tissue slides in which we see that the cytonuclear detail is poor and indistinct nuclear chromatin with nucleoli is sometimes not visible.This artefact can be seen when tissue is not fixated properly.Based on the above investigation, sakura finetek europe decided to report the serious incident as although there was no clinical impact to patients and surveillance interval remains unchanged, the incident could lead to death or the temporary or permanent serious deterioration of a patient's state of health should the event recur.A causal relationship is reasonably possible, i.E.The device cannot reasonably be excluded as a contributory cause of the serious incident, as we are unable to pinpoint the exact root cause of the event.

Event Description

Sakura finetek europe notified sakuta finetek usa on 12- mar-2024 about the incident that occured on 27-feb-2024, the local application specialist was notified by the customer that tissue quality was compromised.The tissue was brittle on embedding and soft on sectioning.Some of the affected tissues were reprocessed and assessed by the pathologist.Samples of 4 patients could not be diagnosed, but there was no clinical impact to patients and surveillance interval remains unchanged.

• Brand Name: TISSUE-TEK VIP® 6 VACUUM INFILTRATION PROCESSOR
• Type of Device: VIP6
• Manufacturer (Section D): SAKURA SEIKI CO., LTD.; nagano yawata shop1122-8; yawata; chikuma city, nagano 387-0 023; JA 387-0023
• 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: 18941740
• MDR Text Key: 338140169
• Report Number: 2083544-2024-00002
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6032
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2011
• 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