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

Model Number ST29TVLH

Device Problem Smoking (1585)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On december 15, 2015, dai-ichi shomei (b)(4) received information that the surgical light generated smoke, a mechanical odor, and stopped operating.

• Brand Name: STELLAR SERIES
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): DAI-ICHI SHOMEI CO., LTD.; 32-26 sakashita 1-chome; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer (Section G): DAI-ICHI SHOMEI CO., LTD.; 32-26 sakashita 1-chome; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer Contact: yoko yoshii ; 32-26 sakashita 1-chome; itabashi-ku, tokyo
• MDR Report Key: 10210386
• MDR Text Key: 197285217
• Report Number: 3006437518-2018-00002
• 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,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST29TVLH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 72 YR
• Patient Weight: 60