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

Model Number	IP BIOPSY CASSETTE II, TAPED, PINK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported ip biopsy cassette ii, taped, pink, p/n: 38440501, lot: 9178512530, where the flange has been breaking off, cassettes opening during processing, and tissue has been lost.Trending analysis from 17 oct 2024 to 17 oct 2025 reported no (0) other related occurrences of this issue for this product lot.The root cause for the "flange has been breaking off, cassettes opening during processing, and tissue has been lost" reported by the customer could not be unequivocally determined from the information available.If additional information is received a follow up mdr will be submitted.
Event or Problem Description
On 13 october 2025, leica biosystems received the following information: "on-site with customer on (b)(6) 2025.Manager [name] informed me of issue with 38440501: ip biopsy cassette ii, taped, pink.Flange has been breaking off, cassettes opening during processing, and tissue has been lost.Issue has occurred all week where tissue is being lost.Per [name], this has occurred with 3 different pas even after particular care is being taken.Pas feel that cassettes seem "softer" and more fragile than previously.Switched to new lot# and taking extra precautions.This site is also using the same cassette in green and yellow, no reported issues." no adverse impact to a patient has been reported to the manufacturer.

• Brand Name: IP BIOPSY CASSETTE II, TAPED, PINK
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): SIMPORT; 4640 avenue fortier; saint hubert 000J3 Y 8K; CA 000J3Y 8K2
• Manufacturer (Section G): SIMPORT; 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: 23491128
• Report Number: 1419341-2025-00038
• Device Sequence Number: 8552459
• 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): 11/06/2025

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, PINK
• Device Catalogue Number: 38440501
• Device Lot Number: 9178512530
• 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: 10/09/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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