MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK VIP(R)5 VACUUM INFILTRATION PROCESSOR FLOOR 230 V, 50 HZ; VIP5

Model Number 5215

Device Problems Degraded (1153); Improper or Incorrect Procedure or Method (2017)

Patient Problem Distress (2329)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Sakura's field service engineer went to site on (b)(4) 2018.The reagents were last replaced on (b)(6) 2018; they are replaced once a week, usually on mondays.The most likely cause of this issue was identified as reagent overfill in station 1 or 2 by user.The lower manifold was filled with liquid with smell of formalin.All stations were pumped in and out; all reagents were returned to the proper station at the correct time.No instrument malfunction was found.Instrument functioned as intended.

Event Description

Sakura finetek usa was informed by user facility that, on (b)(6) 2018, the processed tissue samples were soft, sticky and smelled strongly of formalin and they appeared saturated with water.The tissue-tek vip5 tissue processor, serial number (b)(4), also displayed error code 3 (power outage/unit powered off) and 7 (power back on).Twelve (12) out of approximately 120 affected cassettes/blocks were considered non-diagnostic.Non-diagnostic cases include colon, skin and esophageal biopsies.Site stated that there was some degree of cytological and architectural distortion of all of the biopsies; the biopsies from the distal esophagus demonstrated a degree of distortion of nuclear detail which precludes adequate evaluation to rule in, or rule out, dysplasia and diagnostic assessment was limited in scope given the tissue processing malfunction.Despite careful microscopic examination, nuclear detail and overall tissue appearance was suboptimal for definitive diagnosis.As a result of this issue, 2 patients will require re-biopsy.

Manufacturer Narrative

Sakura's field service engineer (fse) went to site on november 21st, 2018.Based on this investigation, it is believed that the issue was caused by a user error and/or possible worn o-rings on the gate and rotary valve.The fse drained the lower manifold, inspected and greased the gate and rotary valve, replaced the o-rings on the fate and rotary valve, and pumped in/out all stations checking for time and correct return to proper station.He also spoke with the laboratory technicians and talked about proper levels when filling bottles, as the only way the water or immiscible fluid can get in the air lines is by user overfilling the bottles and it is possible that station 1 or 2 were overfilled causing part of the problem.The test runs were preformed after the service and no issue was identified.The instrument is now fully operational.

• Brand Name: TISSUE-TEK VIP(R)5 VACUUM INFILTRATION PROCESSOR FLOOR 230 V, 50 HZ
• Type of Device: VIP5
• Manufacturer (Section D): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• MDR Report Key: 8172206
• MDR Text Key: 130618104
• Report Number: 2083544-2018-00008
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5215
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other