MAUDE Adverse Event Report: DKK DAI-ICHI SHOMEI CO., LTD. AURORA2 SERIES; LIGHT, SURGICAL, FLOOR STANDING

Model Number AUR55

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

According to the importer's evaluation, the cap were loosen due to the impact made by other equipment.

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 april 23, 2015, dai-ichi shomei received information that during a procedure, a staff member was adjusting the light arm.The arm cover above the spindle became loose and fell.Dust entered the patient's incision area.

• Brand Name: AURORA2 SERIES
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: 9498073
• MDR Text Key: 190690510
• Report Number: 3006437518-2019-00003
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUR55
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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