MAUDE Adverse Event Report: THERMO FISHER SCIENTIFIC INC. THERMOFISHER EPREDIA; TISSUE CASSETTE

Catalog Number B851730YW

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2019

Event Type  malfunction  

Event Description

We have what appears to be a new biopsy cassette in yellow.The lids do not fit properly on these cassettes and we are experiencing loose closure and the possibility of tissue free floating during processing.It appears the newer cassettes are lighter in color than our original ones.Also neither the older lids nor the ones that are supposed to be the companion to the lighter colored cassettes is fitting.I am highly concerned about case integrity and patient safety with this happening.This is a serious issue when considering the integrity of the tissue, case, and providing accurate patient results.(above information was from lab director) these samples are irretrievable.So if we compromise identity, we lose the ability to diagnose.Often there is no additional tissue to go back to.Manufacturer response for tissue cassette, (brand not provided) (per site reporter).Hi all, this is very concerning and i certainly understand the gravity of this situation.I'm copying [] on this message as she represents the manufacturer and needs to be included here.All of the cassettes¿biopsy and slotted in all colors are changing to the new part numbers.This has been taking place gradually over the past few months, with the majority of changes occurring over the past few weeks.Some colors were eliminated (as you know), but otherwise, this transition was to be seamless.I'm listing all of your previous part numbers along with the replacement part numbers below.Have you started using any of these new cassettes in other styles/colors? i'd like to determine if the yellow part number is the only problematic color or if this is more widespread.All of the new part numbers begin with "b851.".(email response from [], thermofisher sales rep).

• Brand Name: THERMOFISHER EPREDIA
• Type of Device: TISSUE CASSETTE
• Manufacturer (Section D): THERMO FISHER SCIENTIFIC INC.; 168 third avenue; waltham MA 02451
• MDR Report Key: 9523341
• MDR Text Key: 172837200
• Report Number: 9523341
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2019,12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: B851730YW
• Device Lot Number: I17C9Q1
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1