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

Model Number GI100

Device Problems Product Quality Problem (1506); Protective Measures Problem (3015)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 11/29/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 331341118
• Report Number: 3003423869-2023-00109
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700573004904
• UDI-Public: 05700573004904
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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