MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK PARAFORM BIOPSY CASSETTE,13X13MM

Model Number 7019

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

The customer used a paraform biopsy 13x13 cassette insert without the blue foam which led to a sample being lost.On the packaging of the product insert and ifu, it is stated not to use the insert when the blue foam is missing.The customer in this incident confirmed that the blue foam was not present in the insert when the tissue was applied into the cassette insert; thus, concluding the issue was caused by user error.The customer was informed to follow the ifu to prevent recurrence of the issue.No other incidents can be found in sfe complaint database where a similar issue was reported.It is likely that re-biopsy will be necessary; however, the customer is not willing to pursue this information.Sakura finetek europe b.V.Is unable to retrieve this information and determine the full impact on the patient.

Event Description

On 19-dec-2023 sakura finetek usa received a notification from sakura finetek europe that on 11-dec-2023, the local application specialist from sakura finetek belgium was informed that customer az sint-maarten had lost a tissue sample (oesophagus biopsy) during processing.The sample was placed in a tissue-tek paraform biopsy cassette,13x13mm, which should contain blue foam to keep the sample in place.However, customer noticed after embedding that no tissue was present in the cassette and the blue foam was missing.No other tissue of the patient was available.Sakura finetek belgium requested information if a re-biopsy was needed but the customer was not willing to pursue this information.

• Brand Name: TISSUE-TEK PARAFORM BIOPSY CASSETTE,13X13MM
• Type of Device: PARAFORM 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 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance, CA 90501 ; 3109727800
• MDR Report Key: 18369240
• MDR Text Key: 331048126
• Report Number: 2083544-2023-00008
• Device Sequence Number: 1
• Product Code: IDZ
• UDI-Device Identifier: 00615233080998
• UDI-Public: 00615233080998
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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