MAUDE Adverse Event Report: SAKURA FINETEK U.S.A., INC. TISSUE-TEK®; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Model Number	4223
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mesh biopsy bags are used to hold tissues when grossing to keep them safe, before being inserted into cassettes.The current mesh bags are tearing apart at the edges when opening them to put tissues in and not holding their shape.This gives tissues the potential to be lost out the side of these bags.There has been an increased number of bags tearing apart at the edges causing the grossing tech to throw them away or if they are not caught at the time a potential for loss of irretrievable tissues.

• Brand Name: TISSUE-TEK®
• Common Device Name: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): SAKURA FINETEK U.S.A., INC.; 1750 west 214th st; torrance CA 90501
• MDR Report Key: 19031495
• Report Number: 19031495
• Device Sequence Number: 8120636
• Product Code: NNK
• UDI-Device Identifier: 00615233078391
• UDI-Public: (01)00615233078391
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2023
• Report Date (Section F): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 4223
• Device Catalogue Number: 4223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/19/2023