MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number	14049543268
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 18 november 2022, a customer reported to leica biosystems that on (b)(6) 2022 they experienced suboptimal tissue processing on their leica asp6025, tissue processor.As a result, about 5 cases with multiple tissue (gi biopsies and needle core biopsies) were not able to be diagnosed.
Additional Manufacturer Narrative
The investigation revealed the following: the incident was user related because the user did not change the reagents frequently as required, and the density for bottle s6 (alcohol) was reading only 82%, which is too low and explains the underprocessed tissues.Recommendation from the applications specialist was to reset all the station values manually for everything reagent, which has been changed out so that all of dates are updated and cassettes counts/cycles are cleared, to run a dummy test run without tissues and a cleaning cycle to trigger new density meter readings.The instrument logs were analyzed from the service customer and engineering manager, and no instrument error was detected during the processing steps.After the cleaning run was completed, the user reset bottle s6 to 'full', but according to the concentration measurement after the next processing run, it has been found, that the reagent filled into s6 has a concentration of only 82%, same concentration as the alcohol previously.Therefore, we assume, what they topped into s6 is the reagent.Due to this customer action, 82% alcohol was used in the last step in the processing run and lead to the underprocessed tissues.Further recommendation from the service customer and engineering manager was a re-training of the customer regarding application practices, but the customer informed us, that they no longer have the instrument and therefore no further information or additional instrument logs will be provided.
Additional Manufacturer Narrative
Additional information: added unique identifier (udi) # in d4.

• Brand Name: ASP6025
• Common Device Name: ASP6025
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 15995329
• Report Number: 8010478-2022-00007
• Device Sequence Number: 20323868
• Product Code: IEO
• UDI-Device Identifier: 04049188158826
• UDI-Public: (01)04049188158826
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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 Catalogue Number: 14049543268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown