MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD BOND-III AUTOMATED SLIDE STAINER; SLIDE STAINER, AUTOMATED

Model Number	BOND-III AUTOMATED SLIDE STAINER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for ¿¿there are scratches on the detection tissue after the instrument gets off the plane, and part of the tissue is lost¿ reported by the customer could not be unequivocally determined from the information available.Information provided indicates there was contamination of the reagents, including ¿¿some black particle precipitates¿ and the issue was resolved after cleaning the reagent bottles and replacing reagents.Details of the affected slide staining run(s) were not available to the manufacturer.As a result, it was not possible to assess the operation and function of the instrument.However, based on the information available, the instrument functioned as designed in the circumstances reported by the customer.
Event or Problem Description
On 07 may 2025, leica biosystems received the following information: ¿bond-iii, there are scratches on the detection tissue after the instrument gets off the plane, and part of the tissue is lost.¿ on 09 may 2025, the assigned leica field service engineer (fse) visited the customer site and documented the following information: ¿according to the customer's description, the occurrence of tissue scratches is occasional.On-site inspection revealed that the probe, covertile, slide rack, and ssa were all normal, and no issues were found with the instrument's hardware.Only in the dewaxing solution reagent bottle were some incompatible liquids found, and in the alcohol reagent bottle, some black particle precipitates were discovered.Clean the reagent bottles and replace the contaminated reagents.Test ok.¿ on 10 may 2025, the assigned leica field service engineer (fse) visited the customer site and documented the following information: ¿cleaned dewax and alcohol bottles and replaced the reagents.There were no same problem happening in two days, observing for a while.¿ on 14 may 2025, leica biosystems melbourne received information from the local leica qa specialist, qara that ¿¿this case involves clinical samples and partly involves patients re-biopsy.¿ identifiers for the patients requiring re-biopsy were not available to the manufacturer.

• Brand Name: BOND-III AUTOMATED SLIDE STAINER
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley; victoria 00000-0314 ; AS 0000003149 ; 92117271
• MDR Report Key: 22075475
• Report Number: 8020030-2025-00054
• Device Sequence Number: 9374843
• Product Code: KPA
• UDI-Device Identifier: 09349458000004
• UDI-Public: (01)09349458000004(11)230918
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BOND-III AUTOMATED SLIDE STAINER
• Device Catalogue Number: 21.2201
• 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: 05/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown