MAUDE Adverse Event Report: ACOT PLASTICS CO LTD IP ROUTINE VI TAPED, BLUE; CASSETTES, TISSUE

Model Number	IP ROUTINE VI TAPED, BLUE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported several ip routines vi taped, blue, p/n 39lc-550-2-l, lot 20250519-4 opened during processing.Trending analysis from 23 dec 2024 to 23 dec 2025 reported no (0) other related occurrences of this issue for this product lot.A review of the product history did not identify information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.Retain testing was completed with four (4) cassettes from this lot.The cassettes were ran through the processor on a 4 hour standard factory run on the peloris.After processing none of the cassettes had opened.The root cause could not be unequivocally determined from the information available.If additional information becomes available, a follow-up report will be submitted.
Event or Problem Description
On 22 december 2025, a complaint was raised with the following information: "several cassettes have opened during the processing, lot # 20250519-4." on 05 january 2026, the leica customer care specialist advised the leica associate, quality assurance that the awareness date for this event was 28 november 2025.

• Brand Name: IP ROUTINE VI TAPED, BLUE
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): ACOT PLASTICS CO LTD; malong development district; no. 2 factory building, huli,; xiamen, fujian 00003 6100; CH 0000361006
• Manufacturer (Section G): ACOT PLASTICS CO LTD; malong development district; no. 2 factory building, huli; xiamen, fujian 00003 6100; CH 0000361006
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 24139608
• Report Number: 1419341-2026-00002
• Device Sequence Number: 10399994
• Product Code: IDZ
• UDI-Device Identifier: 20849832018180
• UDI-Public: 20849832018180
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 01/21/2026

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 ROUTINE VI TAPED, BLUE
• Device Catalogue Number: 39LC-550-2-L
• Device Lot Number: 20250519-4
• 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: 11/28/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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