MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025 S; PROCESSOR, TISSUE, AUTOMATED

Model Number	ASP6025 S 120V/50-60 HZ
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigating engineer, quality assurance & regulatory affairs has determined the following: manufacturer cause investigation for leica asp6025 s serial numbers: (b)(6): logfile checks and further analysis determined the following: 1) the ethanol in the d4 bottle was used as the final ethanol step in the affected run, and its concentration, measured by instrument¿s density meter, was 49% - which is far below the required concentration for normal tissue processing.2) the reagent volume in the s5 bottle may be at a critical level, which prevents the reagent from being normally accessed.Manufacturer conclusion for leica asp6025 s serial numbers: (b)(6): the ethanol in the d4 bottle was not replaced in a timely manner as prompted by the on-screen message before the affected run.As a result, the instrument used ethanol with a concentration of only 49% as the final ethanol step in the affected run.Consequently, the water in the tissue could not be completely replaced by ethanol, leading to poor processing quality.Under normal circumstances, the instrument will not use reagents with insufficient concentration.However, since the instrument does not have the capability to handle triple errors: the reagent accessed for the first time has insufficient concentration, the alternative reagent accessed for the second time has insufficient volume, and although the reagent accessed for the third time also has insufficient concentration, the instrument cannot implement corrective measures and thus continues to use it.The following recommendations were provided to the customer: remember to check the reagent volume in each reagent bottle to ensure the reagent level is between the max line and the min line before running the processing protocol.Replace the reagents in a timely manner in accordance with the prompts from the instrument's on-screen messages.(reference: ifu - 5.2.6 ethanol rotation (p110 ¿ p112).
Event or Problem Description
On (b)(6), a customer notified leica biosystems that their "rotina noturna" processing protocol, which began on (b)(6) and ended at 10:16 am on (b)(6), presented a quality deviation.Prior and subsequent processing did not present any issues.The tissue samples processed in the affected run were all large tissue samples.On (b)(6), leica biosystems nussloch gmbh was informed that one tissue sample could not be diagnosed, requiring the patient concerned to undergo a re-biopsy.

• Brand Name: ASP6025 S
• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai, pudong 20120 6; CH 201206
• Manufacturer Contact: sebastian schröder ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143611
• MDR Report Key: 23023743
• Report Number: 8010478-2025-00028
• Device Sequence Number: 18505525
• Product Code: IEO
• UDI-Device Identifier: 04049188210784
• UDI-Public: (01)04049188210784(11)220113
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: ASP6025 S 120V/50-60 HZ
• Device Catalogue Number: 14049559068
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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
• Patient Sex: Unknown