MAUDE Adverse Event Report: DAI-ICHI SHOMEI CO., LTD SKYTRON; SURGICAL LIGHT

Model Number AUR LIGHTS

Device Problems Unintended Collision (1429); Device Fell (4014)

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

Event Type  malfunction  

Event Description

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: SKYTRON
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer (Section G): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer Contact: yoko yoshii ; 32-26 sakashita; itabashi-ku, tokyo 174-0-043 ; JA 174-0043
• MDR Report Key: 7734568
• MDR Text Key: 201839639
• Report Number: 3006437518-2015-00005
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• 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: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AUR LIGHTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1