MAUDE Adverse Event Report: SIMPORT SCIENTIFICQUE INC. IP BIOPSY CASSETTE II, TAPED, GREEN; CASSETTES, TISSUE

Model Number	IP BIOPSY CASSETTE II, TAPED, GREEN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retain samples were not available for further testing.The root cause for "biopsy cassette ii tabs broken" reported by the customer could not be unequivocally determined from the information available.Trending analysis from 10 dec 2024 to 10 dec 2025 reported one (1) other related occurrence of this issue for this product lot.Although the information available indicates that no adverse consequence(s) to a patient(s) has been reported to the manufacturer, the circumstances involved in this complaint have previously resulted in serious injury.If additional information is received a follow up mdr will be submitted.
Event or Problem Description
On 03 december 2025, leica biosystems was made aware of an incident reported to health canada by the customer.The customer provided the following details: "at embedding of outpatient¿s tissue specimen in histology department, there should have been two pieces of tissue in the cassette, but cassette was found empty.Internal tab on cassette was observed to be broken.Grossing basket was empty.One piece was found in the processor retort; the second piece was lost.The found piece of tissue was embedded in block x and three levels were cut and stained with hematoxylin and eosin; pathologist reviewed and confirmed it was the correct tissue type.Slide was labeled as part c.Block x was melted and tissue re-embedded in part c cassette.(tissue specimen was sufficient for pathological analysis; no subsequent procedure was required to procure a second tissue specimen.)" on 03 december 2025, the following information was documented: "tissue specimen was sufficient for pathological analysis; no subsequent procedure was required to procure a second tissue specimen.".

• Brand Name: IP BIOPSY CASSETTE II, TAPED, GREEN
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): SIMPORT SCIENTIFICQUE INC.; 4640 avenue fortier; saint hubert 000J3 Y 8K; CA 000J3Y 8K2
• Manufacturer (Section G): SIMPORT SCIENTIFICQUE INC.; 4640 avenue fortier; saint hubert 000J3 Y 8K; CA 000J3Y 8K2
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 23873393
• Report Number: 1419341-2025-00039
• Device Sequence Number: 5329584
• Product Code: IDZ
• UDI-Device Identifier: 20849832022101
• UDI-Public: 20849832022101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: Health Professional
• Device Model Number: IP BIOPSY CASSETTE II, TAPED, GREEN
• Device Catalogue Number: 38440502
• Device Lot Number: 9309405604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown