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

Model Number ST23LH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Skin Tears (2516)

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

The light was facing upward towards the ceiling; the nurse interviewed indicated that the microscope may have been supporting the light.

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 23, 2015, dai-ichi shomei received information that a nurse was maneuvering a microscope into position for the procedure when the top cover of a surgical light fell from the fixture while the patient was on the surgical table.The nurse did not witness the cover fall, but heard it hit the floor.The patient had minor scratches on their neck.

• 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: 9513463
• MDR Text Key: 190692042
• Report Number: 3006437518-2019-00008
• 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: Non-Healthcare Professional
• 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: ST23LH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2019
• 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: 9 MO