DUO HEADLIGHT 2 BAY SYSTEM - EU
Received Aug 26, 2021 · Event occurred Jul 27, 2021
Report 2523190-2021-00186 · MDR key 12369960
Device
Generic name
Pfm05
Catalog number
90620EU
Product problems
- Unintended Movement
- Unintended Movement
Patient
Not reported
- 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
A FACILITY REPORTED THAT DURING A PROCEDURE, THE DUO HEADLIGHT (90620EU) FIXTURE MOVED DESPITE CORRECT TOUCHDOWN. NO ADVERSE EVENT WAS REPORTED; HOWEVER, A 30-MINUTE INCREASE OF SURGERY TIME DID OCCUR.
Additional Manufacturer Narrative
THE DUO HEADLIGHT WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WAS OBSERVED. FAILURE ANALYSIS: THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE HEADLAMP WAS PROPERLY SEATED AND DOES NOT MOVE. MAINTENANCE WAS CARRIED OUT ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. THE RETURNED HEADLIGHT PASSED INSPECTION AND TESTING. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE: THE ISSUE OF LIGHT FIXTURE MOVING COULD NOT BE DUPLICATED. THIS ISSUE MAY BE THE RESULT OF CUSTOMER PREFERENCE OR ADJUSTMENT ERROR. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.
Description of Event or Problem
N/A.