Description of Event or Problem · 1
HAAG-STREIT USA / HAAG-STREIT SURGICAL HAS DISCOVERED A POSSIBLE CONCERN WITH THE USAGE OF FLOOR STANDS FS 2-11 AND FS 2-15 IN COMBINATION WITH THE OPERATING MICROSCOPES HS HI-R NEO 900, AND HS HI-R NEO 900A DUE TO A SOFTWARE ERROR (SOFTWARE REF.#: (B)(4); VERSIONS: (B)(4)). THE FOCUSING OF THE HS HI-R NEO 900 AND HS HI-R NEO 900A SURGICAL MICROSCOPES ARE OPERATED BY A BUTTON INTEGRATED INTO THE FOOTSWITCH. THE FOCUS MOVES IN BOTH DIRECTIONS UP AND DOWN. WHEN A MOVEMENT OF THE FOCUSING IS TRIGGERED BY PRESSING THE BUTTON OF THE FOOTSWITCH IT MIGHT OCCUR THAT THE MOVEMENT DOES NOT STOP WHEN RELEASING THE BUTTON. THE MICROSCOPE FOCUS MOTOR THEN CONTINUES TO MOVE IN THE DIRECTION OF THE PATIENT UNTIL IT REACHES THE END STOP. THERE THE SOFTWARE SWITCHES OFF THE FOCUS MOTOR. FROM THIS STATE, THE FOCUS COULD BE OPERATED AGAIN AS USUAL. THE SOFTWARE ERROR MAY RESULT IN THE POTENTIAL RISK TO THE PATIENT'S EYE IF EIBOS 2 (FUNDUS OBSERVATION MODULE) IS USED IN AN OPERATION. IF AN ATTEMPT IS MADE TO ADJUST THE IMAGE SHARPNESS USING THE MICROSCOPE FOCUS VIA THE FOOTSWITCH AND NOT WITH THE EIBOS 2 FOCUS LEVER AS DESCRIBED IN THE IFU FOR THE EIBOS 2, IT COULD MOVE INTO THE PATIENT'S EYE IF THE SOFTWARE ERROR OCCURS. DUE TO THE EXISTING PROTECTION FUNCTION (SPRING SUSPENSION), THE EIBOS 2 MOVES 28 MM UPWARDS, WHICH CORRESPONDS TO A FOCUS SPRING SUSPENSION, THE EIBOS 2 MAY BE PUSHED INTO THE EYE, UNLESS THE SURGEON INTERRUPTS THE FOCUS MOVEMENT WITHIN 10 SECONDS BY PRESSING THE FOCUS BUTTON ON THE FOOTSWITCH AGAIN. (B)(4) FDA RECALL COORDINATOR HAS BEEN CONTACTED FOR FIELD ACTION SOFTWARE CORRECTION.