MAUDE Adverse Event Report: DKK DAI-ICHI SHOMEI CO., LTD. AURORA 3 SERIES; LIGHT, SURGICAL, CEILING MOUNTED

Model Number AUT75

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

This peeled/bubbled paint was believed to be caused by improper maintenance such as periodic disinfection and excessive use of cleaning agents.

Event Description

This mdr is being reported at this time as part of an internal review of past complaints.Due to the incident being in the past, the information that can be obtained from the initial reporter is limited.On december 15, 2017, dai-ichi shomei received information that on the rotating part, paint was peeled off and had some bubbles.

• Brand Name: AURORA 3 SERIES
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): DKK DAI-ICHI SHOMEI CO., LTD.; 32-26, sakashita 1-chome; itabashi-ku, 174-0 043; JA 174-0043
• Manufacturer (Section G): DKK DAI-ICHI SHOMEI CO., LTD.; 32-26, sakashita 1-chome; itabashi-ku, 174-0 043; JA 174-0043
• Manufacturer Contact: kenneth block ; 800 e. campbell road; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 9513571
• MDR Text Key: 190691742
• Report Number: 3006437518-2019-00010
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

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
• Device Operator: No Information
• Device Model Number: AUT75
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 12/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other