Pentax of america initiated field correction 2017-008-c which included inspection of the suction arm on affected models pursuant to predefined inspection criteria ((b)(4)).The objective of the inspection was to locate part c255-ab171 (suction arm) and verify it is not loose.If part c255-ab171 (suction arm) is found loose, the device was considered to fail the inspection criteria.The loaner device was previously returned to pentax medical from the customer on 28-oct-2019 for return evaluation.The video naso-pharyngo-laryngoscope was inspected by pentax medical service on 30-oct-2019 and the following inspection findings were documented: suction arm loosen passed wet leak test, customer complaint not stated, passed dry leak test.Inspection of the suction arm was also performed on 30-oct-2019 and the device failed the inspection criteria.The video naso-pharyngo-laryngoscope was repaired including the following components: parts replaced: suction connection tube, insertion/s-nipple attaching screw, o-ring(1.25x3.5), o-ring(1.2x3.5).The video naso-pharyngo-laryngoscope was approved by final qc on 13-nov-2019, and will be released to the loaner pool.
|