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

Model Number	GI100
Medical Device Problem Codes	Product Quality Problem (1506); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a6: not applicable.No patient involvement.This is an isolated incident as all current omnis instruments are manufactured with the guards installed.It was confirmed that there are only two old z-series omnis instruments in the field missing the guards, one of them was the instrument involved in this incident.Additionally, it has been confirmed that guards have been placed on both z-series instruments to prevent a recurrence of this incident.
Event or Problem Description
Agilent field service engineer (fse) states that her left hand was grazed/scrapped by the rotating fan which was missing guards.This injury occurred between her thumb and index finger.There were 3-4 cuts (less than an inch long) and the bleed was stopped once a bandage was applied.The engineer confirmed that her injury has healed.Investigation confirmed that the instrument is a z-series production and was not manufactured with guards on the back side of the bulk fans.The instrument has been serviced and guards were placed on the fans.The instrument is fully operational and is available to the user.This is an internal agilent instrument, no patient diagnosis involved.

• 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: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 18369190
• Report Number: 3003423869-2023-00109
• Device Sequence Number: 7617266
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• 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: 11/29/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2013
• 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