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

Model Number AUR

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

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, the arm cover of the surgical light fell.Before the event, other equipment hit the arm cover, causing it to become loose and later fall.

• 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: 9507098
• MDR Text Key: 190691351
• Report Number: 3006437518-2019-00004
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUR
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other