MAUDE Adverse Event Report: LEICA BIOSYSTEMS LEICA BIOSYSTEMS CYTOVISION GSL

Catalog Number	23GSLXXXKFXUPG
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04 jan 2024 the customer has reported the glue failed on the magnent in the tray, material 23gsl902xxx001, which resulted in breaking five (5) bone marrow slides for one (1) patient while using cytovision, material 23gslxxxkfxupg, serial (b)(6).There was tissue loss.It is unknown if re-biopsy was required.
Additional Manufacturer Narrative
A device history review was completed.There were no deviations or non-conformances associated with this serial number.Trending analysis reported no (0) other related occurrences of this issue for this serial number.The cytovision was cleaned and a new tray was loaded into the system and functioned as expected.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: LEICA BIOSYSTEMS CYTOVISION GSL
• Common Device Name: CYTOVISION GSL
• 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: 18609706
• Report Number: 1419341-2024-00001
• Device Sequence Number: 2406039
• Product Code: NTH
• UDI-Device Identifier: 00849832003762
• UDI-Public: (01)00849832003762(11)200723
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K042542
• 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
• Report Date (Section B): 01/30/2024

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 Catalogue Number: 23GSLXXXKFXUPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown