DUO HEADLIGHT 2 BAY SYSTEM - AU
Received Sep 9, 2021 · Event occurred Aug 18, 2021
Report 2523190-2021-00201 · MDR key 12445554
Device
Generic name
Pfm05
Catalog number
90620AU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Headache
- Headache
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 THE SURGEONS FIND THAT THE DUO HEADLIGHT 2 BAY SYSTEM (90620AU) WAS TOO UNCOMFORTABLE, CAUSING HEADACHES AND DENTS IN THE FOREHEAD. NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGEONS EXPERIENCED THE HEADACHE ONCE AND STOPPED USING THE HEADLIGHT SYSTEM. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY OR SURGICAL DELAY OCCURRED.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM (90620AU) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR): THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS: EVALUATION COULD NOT DUPLICATE THE ISSUE OF DISCOMFORT. HOWEVER, IT WAS FOUND THAT THE GEARS WERE SLIPPING WHEN THE STRAPS ARE PULLED WITH MODERATE FORCE. ADJUSTMENT DUE TO WEAR/MISALIGNMENT HAS BEEN MADE TO CORRECT THIS ISSUE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE: THE RETURNED 90620AU HEADLIGHT PASSED TESTING AND MET SPECIFICATIONS. THE ISSUE OF DISCOMFORT COULD NOT BE DUPLICATED. THE REPORTED ISSUE MAY BE THE RESULT OF CUSTOMER PREFERENCE. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.