MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S

Catalog Number	14047643514
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	11/23/2020
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) 2020, leica biosystems received a complaint that the customer experienced damaged tissue samples during processing on their asp300s.As a result two tissue samples have not been diagnosed.The customer informed leica biosystems, that two men were affected about this adverse event.The age of the two different patients is over 70 years.
Additional Manufacturer Narrative
The incident was presumably user related due to a wrong application from the customer site.Based on the feedback provided by the application engineer, the customer has interchanged the reagents.The customer didn't provide us any other details.The field service engineer wasn't able to find any malfunction of the instrument at the customer site.After correcting and replacing the reagents, the equipment is operating correctly without any problem.
Additional Manufacturer Narrative
Additional information: added unique identifier (udi) # in d4.

• Brand Name: LEICA ASP300S
• Common Device Name: ASP300S
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 11035169
• Report Number: 8010478-2020-00009
• Device Sequence Number: 1087057
• Product Code: IEO
• UDI-Device Identifier: 04049188055972
• UDI-Public: (01)04049188055972
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/27/2023

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: 14047643514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 01/20/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/09/2021; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2010
• 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