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

Model Number AUR LIGHTS

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

On (b)(6) 2015, dai-ichi shomei received information that plastic dust fell from the surgical lights over the operating sites in multiple rooms.This was believed to be caused by the arm of the surgical lights coming in contact with the ceiling covers.

• 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: 7734572
• MDR Text Key: 201839819
• Report Number: 3006437518-2015-00007
• 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: 05/28/2020

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 Model Number: AUR LIGHTS
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 07/31/2018
• 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