MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK PARAFORM BIOPSY-STANDARD CASSETTE; BIOPSY CASSETTE

Model Number 7020-7021

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

Sakura finetek europe b.V application specialist had a follow-up call with the site lab manager after the visit and explained that they had a talk with the entire lab, reminding and refreshing them about the tissue thickness specification when handling tissue-tek paraform cassettes.Further investigation is needed to see if the lids were closed fully/incorrectly, or tissue was indeed cut too thick for the cassettes, causing the lid to pop open.

Event Description

Sakura finetek europe b.V.Became aware on (b)(6) 2023 that patient tissue was not diagnosable and potentially a rebiopsy would be needed.On (b)(6) 2023, a danish customer reported that the lid of two 7020-7021 tissue-tek paraform biopsy-standard cassette opened in the tissuetek autotec a120 instrument (an automated embedding system), causing the tissue to come out of the cassette.The application specialist was called on (b)(6) 2023 after a third cassette lid had opened.A field service engineer visited the customer on (b)(6) 2023 to check the instrument and take the log files for investigation.He concluded that the tissue-tek a120 instrument was working as intended within specification, not causing the cassette lids to open during use of the instrument.He did however discover that the tissue inside the cassette was on the thick side (no pictures), and the temperature in the room was also 30+ degrees on the days on these events.

Manufacturer Narrative

The tissue-tek autotec a120 instrument which is used for embedding patient tissue was checked at the customer location and was deemed to work according to specification.Analyses of the instruments log files supports the conclusion that there is nothing wrong with the instrument, excluding the instrument as root cause of the incident.The manufacturer recommends a thickness of 1.0 to 3.0 mm for tissue in cassettes 7020/7021; however during the customer visit, the field service engineer noticed the tissue in the paraform cassette that the customer uses was on the thick side.The application specialist estimated that the tissue was around 6.0 mm thick.Placing too thick tissue in the cassette can cause the lid to not close correctly and/or create the possibility of the lid to open.During a follow-up call with the lab manager of the customer, they informed the application specialist that they have reminded and refreshed the lab about the way of working described in the ifu when handling paraform cassettes, including the specified thickness of the grossed tissue per cassette type.The customer communicated that they understood the feedback and moving forward would make sure to follow specifications for tissue thickness.The sakura field service engineer (fse) originally reported that they became aware on 06-jul-2023 that the reported incident(s) were potentially reportable, but after further investigation it was determined that the fse actually became aware that the reported incident(s) were potentially reportable on 29-jun-2023.The fse has been re-trained on the product complaint handling sop to ensure they will follow the sop in the future.Capa 02.246.217 has been opened to investigate if further corrective action is needed regarding vigilance training for sakura finetek europe b.V employees.While sakura finetek europe b.V.Initially was informed on 29-jun-2023 that patient tissue was not diagnosable and potentially a re-biopsy would be needed, new information was received on 10-aug-2023 when sakura finetek europe b.V.Was informed by the customer that no re-biopsy was needed and all patients were able to be diagnosed with the remaining tissue from other cassettes.

• Brand Name: TISSUE-TEK PARAFORM BIOPSY-STANDARD CASSETTE
• Type of Device: BIOPSY CASSETTE
• Manufacturer (Section D): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• Manufacturer (Section G): SAKURA FINETEK USA, INC.; 1750 west 214th stree; torrance CA 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501 ; 3109727800
• MDR Report Key: 17398264
• MDR Text Key: 319835955
• Report Number: 2083544-2023-00003
• Device Sequence Number: 1
• Product Code: IDZ
• UDI-Device Identifier: 00615233081001
• UDI-Public: 00615233081001
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7020-7021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other