MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number	14049543267
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/22/2022
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 05 april 2022, a customer reported to leica biosystems that on (b)(6) 2022 they experienced suboptimal tissue processing on their asp6025.As a result the tissue was undiagnosable, and a rebiopsy for 3 patients was recommended.
Additional Manufacturer Narrative
The incident was instrument related about a retort reagent valve problem.The investigation revealed that the retort wax valve o-ring was damaged and lead to a blockage in the liquid line because some debris was found behind the plunger in the valve.The density meter showed relatively high abnormal readings in the paraffin steps as well.The leica biosystems service customer and service engineering manager recommended to replace the retort reagent and retort wax valve, which was conducted from the field service engineer.After the repair, all tests have been passed, and the machine is functioning normally.The customer confirmed that the device has been working correctly since the change and repair.
Additional Manufacturer Narrative
Correction: the type for the follow up 01 "additional information" was not selected.
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: 14276487
• Report Number: 8010478-2022-00004
• Device Sequence Number: 14541551
• Product Code: IEO
• UDI-Device Identifier: 04049188158819
• UDI-Public: (01)04049188158819
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,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): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 05/25/2022; 05/25/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/22/2022; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2017
• 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