MAUDE Adverse Event Report: DKK SKYTRON; SURGICAL LIGHT

Model Number ST2323

Device Problems Device Maintenance Issue (1379); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2015

Event Type  Injury  

Event Description

During a case, the diffuser and lens from a stellar surgical light fell open and debris fell into the surgical field.None of the debris fell into the patient and no injuries were reported.The bulbs for the lights have been changed by the operation room staff.When the light was evaluated, skytron's service tech found that the screw that holds the diffuser/filter assembly in the light was not secure.When it was bumped during surgery, the diffuser/filter assembly opened and debris inside the light fell.Skytron service tech replaced the diffuser/filter assembly and secured it properly.The other diffuser/filter assemblies were checked and secured as needed.The facility has six other operation room with stellar lights.These were checked and the issue was not found in any of the other lights.The facility has moved the responsibility of changing the bulbs to their biomed department to ensure this is done correctly.

• Brand Name: SKYTRON
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): DKK; tokyo ; JA
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 5065168
• MDR Text Key: 25319024
• Report Number: 1825014-2015-00035
• Device Sequence Number: 1
• Product Code: EBA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ST2323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2015
• Distributor Facility Aware Date: 07/31/2015
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention