DUO HEADLIGHT 2 BAY SYSTEM - US

Additional Manufacturer Narrative

THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: THE DEPOT TECHNICIAN'S ASSESSMENT OF THE DUO HEADLIGHT FOUND THAT THE UNIT PASSED ALL THE TESTS AND CHECKS. NO ELECTRICAL SHOCK REGISTERED WHILE TESTING THE UNIT. UNRELATED TO THE REPORTED COMPLAINT, THE UNIT¿S POWER CORD TIE WRAP WAS LOOSENING. THE TIE WRAP WAS REPLACED TO CORRECT THIS ISSUE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE ANALYSIS: THE DUO HEADLIGHT WAS RETURNED IN USED CONDITION WITH DAMAGE TO THE POWER CORD DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. THE ISSUE OF ELECTRIC SHOCK COULD NOT BE DUPLICATED. THE UNIT PASSED ELECTRIC TESTING. THE DAMAGE TO THE TIE WRAP WOULD NOT LEAD TO ELECTRIC SHOCK. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

Description of Event or Problem

A FACILITY REPORTED THAT THE DOCTOR WAS WEARING THE DUO HEADLIGHT 2 BAY SYSTEM (90620US) AND FELT AN ELECTRICAL ¿SHOCK¿. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.