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

Model Number CS100

Device Problems Break (1069); Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.Patient information has not been provided by the user.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.The instrument experienced a similar failure mode related to reportable complaint with injury, reference number mdr (b)(4) mhra 2023/006/021/601/051, agilent cc-0077837.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

Event Description

The danish customer reported the lower door of the coverstainer was broken.Pictures were provided and show the top right corner of the door is broken.The field service engineer (fse) serviced the instrument and replaced the lower door, which resolved this malfunction.This issue does not affect the utility of the instrument and the customer was able to complete staining.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The investigation is ongoing, captured in capa(b)(4) and a supplemental will be provided when new pertinent information is received.

Event Description

No further event information availabe at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Agilent technologies has initiated a recall in (b)(6) 2024 with the scope of notifying all coverstainer customers of the following issue: the lower door that opens to the reagent bottles is cracking and/or breaking off in the upper corner of the plexiglass.Capa01211 has addressed the issue and the investigation has been completed.Agilent technologies has determined the root cause as such; the lower door support bracket, which connects the hinges to the lower door, is only attached to the plexiglass and not to the metal frame which is the main support structure of the lower door.The weight of the plexiglass door is in turn cracking/breaking at this joint.Customers have been notified of this issue via a customer letter.Agilent technologies worked with the manufacturer to re-design the support bracket for the lower door hinges, so the weight of the lower door assembly is not supported by the plexiglass, but by the metal frame of the lower door.This new bracket is being verified for effectiveness; once completed this bracket will be installed at the customer's next service visit.

• Brand Name: DAKO COVERSTAINER
• Type of Device: AUTOMATED SLIDE STAINER, PRODUCT CODE: KPA
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 18962554
• MDR Text Key: 339321488
• Report Number: 3003423869-2024-00019
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700571112571
• UDI-Public: 05700571112571
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS100
• Device Catalogue Number: CS10030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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