ODYSSEY NAVIGATOR DIODE LASER

Description of Event or Problem

A SOFT TISSUE LASER WAS IN USE ON A DENTAL PT. A DISPOSABLE TIP ATTACHED TO THE HANDPIECE OF THE FIBER OPTIC DELIVERY CABLE BECAME DISLODGED FROM THE HANDPIECE AND FELL INTO THE PT'S MOUTH. THE PT SWALLOWED THE TIP BEFORE IT COULD BE RETRIEVED. THE PT REPORTED THAT THE TIP WAS PASSED THROUGH THE DIGESTIVE TRACK AND WAS SEEN IN THE FECAL MATERIAL.

Additional Manufacturer Narrative

REVIEW OF DEVICE DESIGN INDICATED THAT A STACK UP OF TOLERANCES COULD CONTRIBUTE TO A SITUATION WHERE THE DISPOSABLE TIP WOULD NOT BE RETAINED IN THE FIBER OPTIC HANDPIECE, BUT COULD DETACH FROM THE HANDPIECE UNDER ITS OWN WEIGHT OR SUBJECT TO A CENTRIPETAL FORCE. PRIOR TO THE EVENT DATE, REDESIGN OF THE HANDPIECE ASSEMBLY WAS ALREADY COMPLETED TO ADJUST INDIVIDUAL TOLERANCES OF THE RETENTION ASSEMBLY SUCH THAT THE SUM OF TOLERANCES WOULD INCREASE THE RETENTION FORCE ON THE TIP. CONCURRENTLY, ADDITIONAL MFG AND INSPECTION PROCEDURES WERE IMPLEMENTED TO TEST FOR THE TIP RETENTION FORCE. FIBER OPTIC ASSEMBLIES FEATURING THE IMPROVED DESIGN AND PROCESS WHERE MFG STARTING 11/21/2007, AND REPLACEMENT OF OPTICAL FIBER ASSEMBLIES OF PREVIOUS DESIGNS ALREADY ON THE MARKET WAS COMMENCED ON THE SAME DATE. AN UNREPORTED PART 806 CORRECTION IS IN PLACE BY THE DISTRIBUTOR TO REPLACE ORIGINAL DESIGN HANDPIECE TO ALL CUSTOMERS WITH ONE OF A NEW DESIGN.