DUO HEADLIGHT 2 BAY SYSTEM - US
Received Oct 21, 2021
Report 2523190-2021-00228 · MDR key 12678183
Device
Product problems
- Electrical Shorting
- Electrical Shorting
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DUO HEADLIGHT (90620US) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, THE ISSUE OF SHORTING OUT AND EXPOSED WIRES MAY BE THE RESULT OF DAMAGE TO THE POWER CORD OR CORD TIE WRAP. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Description of Event or Problem
N/A.
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 DUO HEADLIGHT (90620US) WAS SHORTING OUT AND HAS EXPOSED WIRES. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY OR SURGICAL DELAY WAS REPORTED.