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

Model Number ST23LH

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Burn(s) (1757); Injury (2348); Superficial (First Degree) Burn (2685); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

According to the service technician's inspection records, detergents remained on the diffuser.Suggested was a review of cleaning detergents and cleaning methods.

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 28, 2015, dai-ichi shomei received information that during a leg procedure, the surgical light was 24" away from a wrapped patient's leg when the physician confirmed that the wrap was hot.The wrap was stuck to the leg skin and caused a burn or blister upon removal.

• 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: 9498069
• MDR Text Key: 187934525
• Report Number: 3006437518-2019-00002
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K002463
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ST23LH
• Was Device Available for Evaluation?: No
• Device Age: 10 YR
• Date Manufacturer Received: 04/13/2015
• 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