MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE SPECTRA CV; MICROSCOPE SLIDE COVERSLIPPER IVD

Model Number	HISTOCORE SPECTRA CV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their histocore spectra cv, microscope slide coverslipper.As a result, the samples were damaged, but no new rebiopsy was necessary.
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.
Additional Manufacturer Narrative
The investigation revealed that this incident was related due to an adjustment issue.The root cause was, that the coverslip line 2 was not functioning correctly.The field service engineer detected a that the shifter tongue of the coverslip line was a little bit bent and therefore under the shifter parts of a broken slide.The field service engineer removed the debris and adjusted shifter tongue of the coverslip line.The performance test was conducted as per instructions from the service manual and the instrument is up and running according to the specification.The customer accepted the instrument for the routine usage.Since the repair has been carried out leica biosystems nussloch gmbh has not been made aware by the customer of any further issues with this instrument related to the incident described in this report.

• Brand Name: HISTOCORE SPECTRA CV
• Common Device Name: MICROSCOPE SLIDE COVERSLIPPER IVD
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226
• Manufacturer Contact: andreas helmstetter ; heidelbergerstr. 17-19; nussloch 69226 ; GM 69226 ; 0496224143413
• MDR Report Key: 21147756
• Report Number: 8010478-2025-00019
• Device Sequence Number: 13070710
• Product Code: KIM
• UDI-Device Identifier: 04049188203953
• UDI-Public: (01)04049188203953(11)230517
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Model Number: HISTOCORE SPECTRA CV
• Device Catalogue Number: 14051454200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown