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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAKURA FINETEK U.S.A., INC. TISSUE-TEK®; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
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SAKURA FINETEK U.S.A., INC. TISSUE-TEK®; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE Back to Search Results
Model Number 4223
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2023
Event Type  malfunction  
Event 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.
 
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Brand Name
TISSUE-TEK®
Type of Device
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 Key19031495
MDR Text Key339230884
Report Number19031495
Device Sequence Number1
Product Code NNK
UDI-Device Identifier00615233078391
UDI-Public(01)00615233078391
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/19/2023,10/16/2023
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
Device Operator Other
Device Model Number4223
Device Catalogue Number4223
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/19/2023
Event Location Hospital
Date Report to Manufacturer04/03/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/03/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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