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

Model Number ST29

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

According to the importer's evaluation, the original oem parts were not used by unautorized representative.

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 december 15, 2015, dai-ichi shomei received information that the surgical light generated smoke, a mechanical odor, and stopped operating.

• Brand Name: STELLAR 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: 9513518
• MDR Text Key: 172503226
• Report Number: 3006437518-2019-00011
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

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 Operator: Health Professional
• Device Model Number: ST29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/23/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 60