MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number	14049543267
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 leica biosystems received the complaint confirmation, that the customer experienced suboptimal tissue processing on their leica asp6025 leading to the tissue damage.The affected tissues were being brittle as well as showing poor nuclear detail.On (b)(6) 2023 leica biosystems received final confirmation that 9 patient samples could not be successfully diagnosed and a re-biopsy of the patients concerned will therefore be required.
Additional Manufacturer Narrative
As determined by the investigating field service engineer, due to a recent supplier change, the customer now receives all liquid reagents in identically coloured bottles, making it difficult to distinguish between different reagents.This change was implemented without prior information of laboratory personnel.The new reagent bottles together with the lack of information regarding this change caused the laboratory personnel to mistakenly replace the xylene in d3 (the final clearing step before proceeding to the wax infiltration steps) not with fresh xylene, but with acid alcohol.This in turn caused the affected tissue samples to become dry and brittle, making them difficult to section.The customer was advised by the responsible leica biosystems representative to exchange all xylene and wax reagents on the affected instrument.This has since occured.After exchanging all affected reagents the customer has returned the device to regular use without any further issues reported.

• Brand Name: ASP6025
• Common Device Name: ASP6025
• 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: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17974042
• Report Number: 8010478-2023-00013
• Device Sequence Number: 11385677
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 10/20/2023

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: 14049543267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2016
• 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