SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE DURING THE EXECUTION OF REPROCESSING PROTOCOL SENSICA TOUCHSCREEN FIRMWARE UPDATE FIELD ACTION, AT THE US DEPOT, THE UNIT WAS GIVING THE TECHNICIAN A TUBE SENSOR ERROR WITH NO TUBE INSTALLED. DEVICE PERFORMANCE ISSUES RELATED TO PHANTOM TOUCHES THAT MIGHT OCCUR AFTER CLEANING WITH CLEANING AND DISINFECTING WIPES AND TO INACCURATE VOLUME MEASUREMENTS. ALL PACKAGING WAS REPLACED DUE TO DAMAGE FROM GDC. TUBE SENSOR INDICATING ACTUATED WHEN TUBE NOT INSERTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. H11: SECTION A THROUGH F THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE DURING THE EXECUTION OF REPROCESSING PROTOCOL SENSICA TOUCHSCREEN FIRMWARE UPDATE FIELD ACTION, AT THE US DEPOT, THE UNIT WAS GIVING THE TECHNICIAN A TUBE SENSOR ERROR WITH NO TUBE INSTALLED. DEVICE PERFORMANCE ISSUES RELATED TO PHANTOM TOUCHES THAT MIGHT OCCUR AFTER CLEANING WITH CLEANING AND DISINFECTING WIPES AND TO INACCURATE VOLUME MEASUREMENTS. ALL PACKAGING WAS REPLACED DUE TO DAMAGE FROM GDC. TUBE SENSOR INDICATING ACTUATED WHEN TUBE NOT INSERTED.