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	06/02/2021
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 02 august 2021 leica biosystems received a complaint that the customer experienced damaged tissue samples during processing on their asp6025.As a result 3 tissue samples have not been diagnosed.
Additional Manufacturer Narrative
The investigation revealed that this incident was presumably user related.The instrument logs were analyzed and no error was detected during the processing steps.A field service scientist has also been onsite and performed some tests with the cassettes the customer has been used (simport (m507 - micromesh ¿ biopsy cassettes), and has compared the simport cassettes with the micromesh cassettes from leica (ip activflo biopsy iii cassettes).The tests were performed in the presence of the customer and showed, that the leica cassettes immerse faster in formalin than the simport cassettes, and the leica cassettes empty the reagents faster than the simport cassettes.As result, the recommendation was to use the leica cassettes, because several tests were performed with the leica cassettes and good results.Additionally recommendation from the field service scientist was to modify the processing protocol regarding the leica recommended protocol.
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, ; GM
• MDR Report Key: 12335207
• Report Number: 8010478-2021-00010
• Device Sequence Number: 2825668
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: 08/02/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 08/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/28/2021; 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