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

Catalog Number 7019

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Distress (2329)

Event Date 01/19/2018

Event Type  Injury  

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.

Event Description

On (b)(6) 2018, sakura finetek usa, inc.Was notified that a user lost a patient's specimen (cardiac biopsy) on (b)(6) 2018.A grossing technician used a sakura's 13x13 biopsy paraform insert (product code 7019) without noticing the sponge in the lid was missing.The specimen was lost during processing on a peloris processing instrument by (b)(6).

• 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: 7300749
• MDR Text Key: 101093116
• Report Number: 2083544-2018-00004
• Device Sequence Number: 1
• Product Code: IDZ
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other