MAUDE Adverse Event Report: STRYKER CORP VISUM LED 2; OR LIGHTS

Model Number VISUM II

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 02/10/2016

Event Type  malfunction  

Event Description

Skin injury to outer chest during the operative process in cv operating room 2.Third party investigation revealed preliminary findings that the combination of prep and the lights may cause increased skin temperature.Final analysis pending.

• Brand Name: VISUM LED 2
• Type of Device: OR LIGHTS
• Manufacturer (Section D): STRYKER CORP; 1410 lakeside parkway, ste. 100; flower mound TX 75028
• MDR Report Key: 5547249
• MDR Text Key: 41876384
• Report Number: 5547249
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: VISUM II
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALCOHOL-MEDICHOICE ORDER (B)(4) DISTRIBUTED
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 78