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	04/18/2023
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) 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their asp6025, tissue processor.On (b)(6) 2023 the customer informed leica biosystems, that as a result, 5 tissue samples have not been diagnosed.
Additional Manufacturer Narrative
The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected during the processing steps related to the damaged tissue.The incident was user related and caused by the usage of the incorrect processing protocol.The large tissues and biopsy tissues were processed together with the same overnight protocol.A customer facing letter will be sent out to the customer with the recommendation.To consider the usage of the recommended processing protocol for standard biopsy and small specimens as defined in the instruction for use (ifu).The biopsy tissue should be processed with a biopsy protocol, while the large tissue should be processed using an overnight protocol.If the customer wants to like to process both tissue types together, the protocol should be validated by the customer prior to usage and processing of clinical samples.
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; 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: 17009254
• Report Number: 8010478-2023-00005
• Device Sequence Number: 7538458
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 07/21/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 08/08/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2017
• 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