DUO HEADLIGHT 2 BAY SYSTEM - US
Received Feb 5, 2025
Report 3006697299-2025-00011 · MDR key 21314934
Device
Generic name
Pfm05
Manufacturer
Integra Lifesciences (ireland) Ltd.Catalog number
90620US
Lot number
L005447IE
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) OVERHEATED AND STARTED TO "STROBE" DURING A PROCEDURE. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE SURGERY WAS NOT DELAYED DUE TO THE HEADLIGHT ISSUE.
Additional Manufacturer Narrative
CORRECTED FIELD: E1 (REPORTING FACILITY). THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE RETURNED DUO HEADLIGHT WAS IN USED CONDITION. THE UNIT WAS RETURNED WITH DUO HEADLIGHT AND A HOLSTER. EVALUATION FOUND THAT THE FAN DOES NOT TURN ON, CAUSING OVERHEATING AND FLICKERING. THE UNIT ALSO FAILED LARGE SPOT SIZE AND UNIFORMITY TESTS. SINCE THE UNIT IS AN IE UNIT, IT MUST BE RETIRED. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THE IDENTIFIED DAMAGES WERE MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
N/A