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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

Preliminary investigation results show that the ivd device was working according to specifications.Further investigation is needed to determine the root cause of the reported incident.Note: this unit tissue-tek vip 6 tissue processor, serial (b)(6) is passed the 7 year lifecyle from dom of 10-feb-2011.

Event Description

Sakura finetek europe notified sakura finetek usa on 8/11/2023 that on the (b)(6) 2023, a customer based in the uk reported poor processing while using the tissue-tek vip 6 tissue processor.Customer had processed 210 blocks of which 70 blocks were affected containing various types of tissue.Blocks could not be properly cut at microtomy and some could not be stained as normal.Customer reported a minimum of three specimen lost and needed rebiopies, the final number is still to be confirmed.

• 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: 17613928
• MDR Text Key: 321860452
• Report Number: 2083544-2023-00005
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/22/2023

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?: Yes
• Device Model Number: 6032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2011
• 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