MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number	14049543267R
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	04/06/2021
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 (b)(6) 2021 leica biosystems received a complaint that the customer experienced damaged tissue samples during processing on their asp6025.As a result 2 tissue samples have not been diagnosed; 1 tissue sample belonging to a female patient and 1 tissue sample belonging to a male patient.The 1 male patient tissue sample could not be diagnosed.
Additional Manufacturer Narrative
The instrument logs were evaluated by a service support manager.The investigation revealed the following: no error detected during the processing steps, there was an abnormality, but only in the cleaning step without tissue involved.Presumably, the cause for the suboptimal processed tissue was due to an application issue.The customer interrupted the cycle several time before the end, and this could have been the root cause of the issue.Due to issues using the concentration mode, the customer switched to the instrument reagent management system (rms) mode.Additionally the asp6025 main pcba was replaced.The customer confirmed that the device is working correctly since the change to the instrument rms mode.
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; 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, 69226 ; GM 69226
• MDR Report Key: 11778677
• Report Number: 8010478-2021-00005
• Device Sequence Number: 3647221
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 14049543267R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 06/29/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/02/2021; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2018
• 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: Male