MAUDE Adverse Event Report: LEICA BIOSYSTEMS CYTOVISION; DEVICE, AUTOMATED CELL-LOCATING

Model Number	GSL UPGRADE TO CURRENT SPECIFICATIONS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review was completed.There were no deviations or non-conformances associated with this lot.Trending analysis reported one (1) other related occurrence of this issue for this product lot.Quality control testing was complete and passed.A customer returned sample was requested.If additional information is received an additional follow up mdr will be submitted.
Event or Problem Description
On oct 8th the customer reported an error loading & unloading, failing to move to correct location on the stage and scans of a previously scanned/captured slide when the system says it's on a subsequent slide for material 23gslxxxkfxupg for cytovision sn# (b)(6).No loss of patient data.
Additional Manufacturer Narrative
Added h6 type of investigation, investigation findings, and investigation conclusions.Customer return was tested and investigation identified normal wear and tear leading to intermittent component failures.If additional information is received an additional follow up mdr will be submitted.
Additional Manufacturer Narrative
The awareness date for submission 1419341-2024-00012 follow-up 1 was incorrectly entered in section g3/4.The correct date was 07 november 2024.

• Brand Name: CYTOVISION
• Common Device Name: DEVICE, AUTOMATED CELL-LOCATING
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us-12; richmond IL 60071
• Manufacturer (Section G): LEICA BIOSYSTEMS; 5205 us-12; richmond IL 60071
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 20615549
• Report Number: 1419341-2024-00012
• Device Sequence Number: 8873998
• Product Code: JOY
• UDI-Device Identifier: 00849832003762
• UDI-Public: (01)00849832003762(11)210621
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GSL UPGRADE TO CURRENT SPECIFICATIONS
• Device Catalogue Number: 23GSLXXXKFXUPG
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 05/30/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/03/2024; 06/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown