DUO LITHIUM ION BATTERIES - QUANTITY TWO

Additional Manufacturer Narrative

UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DUO LITHIUM ION BATTERIES - QUANTITY TWO (90622) WAS NOT WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. BASED ON THE REPORTED COMPLAINT, THE PROBABLE ROOT CAUSE FOR THIS DUO LITHIUM ION BATTERY BEING DEFECTIVE COULD BE DUE TO A MALFUNCTIONING BATTERY CHARGER. HOWEVER, A DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. 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

UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DUO LITHIUM-ION BATTERIES - QUANTITY TWO (90622) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE RETURNED DUO LITHIUM-ION BATTERIES WERE IN USED CONDITION. A VISUAL/FUNCTIONAL CHECK WAS PERFORMED ON THE BATTERIES. THERE ARE NO VISUAL PROBLEMS WITH THE BATTERIES, AND THEY ARE ABLE TO CHARGE TO FULL WITH A 90624US CHARGER WITHOUT ISSUE. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE: THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE BATTERIES WERE ABLE TO FULLY CHARGE USING A 90624US CHARGER. THE ISSUE OF THE BATTERIES NOT PERFORMING PROPERLY COULD BE DUE TO A MALFUNCTIONING CHARGER. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED.

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 DUO LITHIUM-ION BATTERIES - QUANTITY (B)(4) (90622) DOES NOT FULLY CHARGE AND DOES NOT LAST LONG AFTER CHARGING, CAUSING SIGNIFICANT DELAYS IN THE OPERATING ROOM. IT WAS FURTHER REPORTED THAT "DURING SURGERY, THE BATTERIES WOULD RUN OUT QUICKLY AND NOT CHARGE", CAUSING AN INCREASE IN SURGICAL TIME OF MORE THAN 30 MINUTES. ADDITIONALLY, IN SOME CASES STAFF "USED BATTERIES THAT STILL WORKED, IN OTHERS THEY USED THE LIGHT FROM THE OPERATING ROOM LAMP AND OTHER TIMES THEY USED THE CABLE AC DIRECTLY CONNECTED TO THE WALL"; HOWEVER, THE SURGEON WAS DISSATISFIED. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED.