MAUDE Adverse Event Report: LEICA BIOSYSTEMS LEICA BIOSYSTEMS CYTOVISION GSL

Catalog Number 23GSLXXXKFXUPG

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 335084272
• Report Number: 1419341-2024-00001
• Device Sequence Number: 1
• Product Code: NTH
• UDI-Device Identifier: 00849832003762
• UDI-Public: (01)00849832003762(11)200723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23GSLXXXKFXUPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other