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

Model Number	GI100
Medical Device Problem Codes	Break (1069); Sparking (2595); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The agilent field service engineer (fse) in norway reported, during an unrelated service for the omnis instrument, it was discovered the sheath insulation of the electrical power cable coming from the uninterruptable power supply (ups) and the sheath insulation of the wires beneath this were damaged and exposed producing sparks.No one was harmed, no medical attention was needed, and there was no fire or smoke as a result of this issue.The fse replaced the power cable and made sure it was secured in a position where it could not cause a reoccurring event; resolving the malfunction.The customer was able to complete staining with another instrument.The instrument is fully operational, within specification, and ready for use.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.The investigation determined the power cable was damaged by a bracket of the omnis that is part of the lifting function of the instrument.This bracket is part of the track for the leveling mechanism for the back foot that runs through and sits behind the ups where the power cable is connected.This bracket is not involved in mounting or securing the cable; this cable typically runs away from the bracket out the back right side of the instrument.The back standing foot is lowered and raised by a mechanism (shaft) on the front of the instrument.When turning the shaft there is a metal plate (bracket) that moves back and forth in the instrument.In this situation, it is this back-and-forth movement of the bracket that caused the damage to the power cable.Every time the instrument is serviced by agilent, the fse raises and lowers the back standing foot and moves the instrument to reach the back of the instrument.While the exact cause of how the cable arrived at this improper location is unknown it is believed that the cable was mistakenly mounted in a vulnerable position during installation.This event is confirmed to be an isolated incident; a review of all complaints has shown no similar issues have been reported.
Additional Manufacturer Narrative
No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1:, a6: patient information has not been provided by the user.
Additional Manufacturer Narrative
This follow up report is being submitted to correct the following fields: b4, d4, g1, g3, g6, h2, h6, h11.

• Brand Name: DAKO OMNIS
• 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: angela bandy ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 19063758
• Report Number: 3003423869-2024-00023
• Device Sequence Number: 20502366
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: (01)05700573004904(11)160914(21)1609000806
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2016
• 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