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	Tissue Breakdown (2681)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Event or Problem Description
On 21 june 2021 leica biosystems received a complaint that the customer experienced damaged tissue samples during processing on their asp6025.As a result 1 tissue sample from one patient has not been diagnosed.
Additional Manufacturer Narrative
The instrument logs were evaluated by a service support manager.The investigation revealed the following: no obvious problem was noticed from the io level logs, and no error was detected during the processing steps.A field service engineer has also been onsite but could not find any errors on the instrument and it passed all of the tests.Presumably, the cause for the suboptimal processed tissue was due to an application issue, because the concentration of the absolute alcohols in the last bottle was very low.It should have 98% absolute alcohol or higher.The last bottle must be the newest, but it was detected, that there are the oldest in this affected instrument.This observation was made by analyzing the reagent status of the instrument log files.Therefore, there is no increasing reagent quality (s1 - s6, oldest bottle - newest bottle) and concentration in the alcohol stations.This leads to insufficient dehydration during processing.According to the sent log files, the bottles s1 to s3 were renewed on 16th of june, but the other bottles are older.Autorotation cannot be initiated when only some alcohol stations are exchanged like this.This leads to improper removal of water from the tissue, and can be result in damaged tissues.Additionally, the leica biosystems application consultant from the customer support requested, that the customer changes the paraffin in bath i urgently due to xylene contamination.Furthermore, after discussions with the customer, the thresholds of the reagents were adjusted to improve the tissue processing quality and reduce xylene contamination in paraffin.There were also signs of cross contamination as paraffin was found in the absolute ethanol bottles and crystalline fragments in one alcohol bottle.The service support instructed the field specialists to service the liquid valves, performing a smart clean to thoroughly clean the lines of the instrument and exchange the reagents.

• Brand Name: ASP6025
• Common Device Name: ASP6025
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 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, ; GM
• MDR Report Key: 12189750
• Report Number: 8010478-2021-00008
• Device Sequence Number: 11093543
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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
• Device Catalogue Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 08/18/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/19/2021; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2015
• 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