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

Model Number	IP BIOPSY CASSETTE II, TAPED, PINK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the customer contacted leica biosystems and reported ".A cassette lid broke and tissue escaped during processing and was lost." no adverse impact to any patient has been reported to the manufacturer.
Additional Manufacturer Narrative
The customer reported ip biopsy cassette ii, taped, pink, p/n 38440501, lot 9132511120 cassette lid broke, the tissue escaped during processing and was lost.The patient did not have to be re-biopsied for diagnosis.Trending analysis from (b)(6) 2025 to (b)(6) 2026 reported no (0) other related occurrences of this issue for this product lot.The product history was reviewed and did not identify information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.Product retained was examined by repeated opening and closing of cassette to assess for the tab breaking off.Tab breaking off was not able to be replicated.The root cause for the "cassette lid broke and tissue escaped during processing and was lost" could not be determined from the information available.If additional information is received a follow-up report will be submitted.

• Brand Name: IP BIOPSY CASSETTE II, TAPED, PINK
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): SIMPORT SCIENTIFIQUE INC.; 4640 avenue fortier; saint hubert 000J3 Y 8K; CA 000J3Y 8K2
• Manufacturer (Section G): SIMPORT SCIENTIFIQUE 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: 24973940
• Report Number: 1419341-2026-00007
• Device Sequence Number: 4954371
• Product Code: IDZ
• UDI-Device Identifier: 20849832022095
• UDI-Public: 20849832022095
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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): 04/24/2026

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, PINK
• Device Catalogue Number: 38440501
• Device Lot Number: 9132511120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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