MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND INC. ACTIVFLO ROUTINE I-TAPED-YELLOW 1000; CASSETTES, TISSUE

Model Number	ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported activflo routine i-taped-yellow 1000, p/n: 39lc-500-9-l, lot: 20240716 was popping open.The small plastic locking pieces on the front of the cassette are weaker than usual and have been breaking or not strong enough to lock properly.No adverse events were reported.Trending analysis from 13 jun 2024 to 13 jun 2025 reported no (0) other related occurrences of this issue for this product lot.The product history was reviewed and did not identify any information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.As manufacturer investigation of this complaint by leica biosystems is in progress, the root cause of this event has not yet been determined.If additional information is received a follow up mdr will be submitted.
Event or Problem Description
On 31 may 2025, leica biosystems received the following information: "the pa's have been having issues with the yellow cassettes "popping" back open.Seems like the small plastic locking pieces on the front of the cassette are weaker than usual and have been breaking or not strong enough to lock properly." on (b)(6) 2025, the customer advised "there was no loss of tissue.The issue was noticed at grossing.The lids would keep popping back open, so they¿d print new cassettes until they got some that stayed close.It only was an issue at grossing.No re biopsy needed.It was all types of our rush cases: breast, lung, kidney, colon etc." no adverse consequence(s) to a patient(s) has been reported to the manufacturer to date.
Additional Manufacturer Narrative
Manufacturer testing of retain samples was unable to replicate the "yellow cassettes "popping" back open" reported by the customer.The root cause for the "yellow cassettes "popping" back open" reported by the customer could not be unequivocally determined from the information available.If additional information is received an additional follow up mdr will be submitted.
Additional Manufacturer Narrative
The awareness date for submission 1419341-2025-00030 was incorrectly entered in section g3/4.The correct date was 30 may 2025.

• Brand Name: ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer (Section G): XIAMEN VOKE MOLD & PLASTIC ENGINEER; no. 1152-1160 and no.1166-1170; chun guang rd,; xiamen city, fujian province 00003 6110; CH 0000361101
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 22333395
• Report Number: 1419341-2025-00030
• Device Sequence Number: 9129042
• Product Code: IDZ
• UDI-Device Identifier: 20849832022446
• UDI-Public: 20849832022446
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup
• Report Date (Section B): 10/30/2025

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: ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
• Device Catalogue Number: 39LC-500-9-L
• Device Lot Number: 20240716
• 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: 05/31/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 10/15/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/11/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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