MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. TISSUE-TEK VIP(R)6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ; VIP6

Model Number 6030

Device Problem Inadequate User Interface (2958)

Patient Problem Distress (2329)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Sakura service technician was at site on december 4, 2019, and tested unit operation.Site had cleaned all paraffin tanks and replaced all paraffin.The service technician pumped in and out of paraffin station 1 and 2, did not see formalin in the paraffin.All level sensors were tested good.Unit were retested, operated to sakura specifications, no issue was identified.The most likely cause of the issue is user error; user did not realize that the retort was full of formalin from station #2, filled it with fresh formalin and when it drained back, it caused overflowed and contamination.Site reported on december 9, 2019, that they replaced all reagents and paraffin on (b)(6) 2019, and ran 2 days with no issues.

Event Description

Site stated that there was formalin contamination on (b)(6) 2019, in paraffin station #13 of the tissue-tek vip6 instrument.They were not able to embed the tissues and get the slides.Tissues were floating on paraffin during embedding as they were very soft and spongy.Eighty (80) out of 97 tissues were affected.One patient required re-biopsy for gi specimen as a result.They were able to make diagnosis for other patients after re-cutting and/or re-processing their tissue samples.

• Brand Name: TISSUE-TEK VIP(R)6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ
• Type of Device: VIP6
• Manufacturer (Section D): SAKURA SEIKI CO., LTD.; 75-5, imojiya; chikuma, 387-0 015; JA 387-0015
• Manufacturer (Section G): SAKURA SEIKI CO., LTD.; 75-5, imojiya; chikuma, 387-0 015; JA 387-0015
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance 90501 ; 3109727800
• MDR Report Key: 9484687
• MDR Text Key: 188652576
• Report Number: 2083544-2019-00005
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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