MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK(R) VIP6 TISSUE PROCESSOR, 230 VAC, 50HZ

Model Number 6032

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Sakura finetek europe provided investigation for this incident.The investigation shows that the customer tried to start a run while the mandatory cleaning between runs was not done yet.As "start" was selected, we assume there were samples inside the retort.Upon not being able to start the run, the user took out the samples again, leaving a certain volume of eosin enriched formalin inside the retort that subsequently was purged in paraffin container 14 when starting the cleaning run.The run after the cleaning run was the affected run reported by the customer.Reagents were analyzed and showed no abnormal signs, except for the formalin smell and eosin seen in paraffin container 14.This contamination has been found to be the rootcause of the incident.From technical point of view there is no sign of a system failure that could have cause the incident, the pressures, positive and negative are in range, the timings are correct, and the temperatures are as expected.On 15-mar-2024, the customer communicated the following numbers concerning patient impact: total number of blocs saved after another run or technically usable: 191.Total number of blocs lost : 21.Total number of cases impacted by lost blocs : 9.

Event Description

Sakura finetek europe notified sakura finetek usa on 22-feb-2024 that on 15-feb-2024, the french application specialist was made aware of an incident with the tissue-tek vip® 6 vacuum infiltration processor at a french customer.Customer was processing a run overnight which ended normally, but when the customer opened the retort of the instrument in the morning, customer smelled formalin.All samples in that run (204 biopsies) have been affected, but the impact on the patients is currently unclear.Customer found formalin contamination in the last paraffin container.

• Brand Name: TISSUE-TEK(R) VIP6 TISSUE PROCESSOR, 230 VAC, 50HZ
• 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 387-0 023; JA 387-0023
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501
• MDR Report Key: 18936487
• MDR Text Key: 338071161
• Report Number: 2083544-2024-00001
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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