MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. DAKO COVERSTAINER; AUTOMATED SLIDE STAINER

Model Number	CS100
Medical Device Problem Codes	Mechanical Problem (1384); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The brazil customer reported that the recently installed dako coverstainer lower doors shock absorbers, which are used to support the door, did "not support the door properly." clarification was received from the agilent representative noting that the shock absorbers did not have sufficient force to securely hold the door open particularly during reagent bottle changes.User harm was not indicated or reported.The field service engineer (fse) serviced the instrument and replaced the shock absorbers.The instrument has been repaired; it is fully operational and is available to the user.This issue does not affect the utility of the instrument, and the customer was able to complete staining.While there was no direct, or indirect, user harm reported for this event; it is being reported due to the potential for harm if the event were to reoccur.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.
Event or Problem Description
Following further review, and input from the relevant agilent representatives, it has been determined that this event occurred during the installation of the instrument at the customer's site.While the instrument was new to the customer, it had previously been owned and operated by agilent technologies.During installation, the field service engineer (fse) identified that the lower door shock absorbers did not provide sufficient force to securely hold the door in the open position.To resolve this, the fse replaced the shock absorbers prior to releasing the instrument to the customer.As the issue was identified and corrected before the instrument was placed into service, the customer was not exposed to any risk of harm or injury related to the shock absorbers.
Additional Manufacturer Narrative
Following sections were updated: b4, h2.Following section was corrected: b5, d5, e1, e3, g2, g6.

• Brand Name: DAKO COVERSTAINER
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: benjamin gaither ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328207
• MDR Report Key: 23429780
• Report Number: 3003423869-2025-00046
• Device Sequence Number: 8242329
• Product Code: KPA
• UDI-Device Identifier: 05700571112571
• UDI-Public: (01)05700571112571(11)211001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: CS100
• Device Catalogue Number: CS10030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sex: Unknown