MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM

Catalog Number 7019

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)

Patient Problems No Information (3190); Missing Value Reason (3192)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

The foam is inserted in the cassette as a convenience for the lab technicians.Due to the nature of the foam, the foam may detach from the cassette lid.As such sakura had added a warning label to each box as an additional safety factor to further warn the user to ensure the foam is in place before use.Furthermore, it is required by the operating manual, and training provided to the technicians to place the tissue on the foam in order to ensure the presence of the foam.Technicians are aware of this as this information is present in the instructions for use and it is also a subject during required hands on training.

Event Description

On (b)(6) 2017, sakura finetek usa, inc.Was notified that a user site in the (b)(6) reported an incident which occurred on (b)(6)2016 and involved sakura's paraform 13x13 cassette.Site stated that one gastric biopsy containing 3 fragments, all 2 mm, was lost during processing and no tissue was made available for histological examination because the lab technician did not verify presence of the foam inside the cassette during embedding process.Furthermore, the lab technician failed to follow the instruction of placing tissue on the foam, as described in the instructions for use.The endoscopic report was issued, stated that the tissue was lost during processing, therefore, no histological assessment could be made.

• Brand Name: TISSUE-TEK(R) PARAFORM BIOPSY CASSETTE, 13 X 13 MM
• 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 street; torrance CA 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501 ; 3109727800
• MDR Report Key: 6718985
• MDR Text Key: 80432888
• Report Number: 2083544-2017-00001
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7019
• Device Lot Number: PM16165D03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other