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

Model Number ST2323

Device Problems Misassembled (1398); Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problems Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

Upon further investigation, it was discovered that when replacing the acrylic cover, the uv filter was discarded by mistake.The acrylic cover was then replaced with no filter.Using the surgical light with no uv filter is believed to have caused this patient's burn.Follow-up report(s) will be submitted upon obtaining any additional information.

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 16, 2015, dai-ichi shomei received information that the surgical light caused a burn injury to the patient.

• Brand Name: STELLAR 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: 9513551
• MDR Text Key: 190691642
• Report Number: 3006437518-2019-00012
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002463
• 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

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST2323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2015
• 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