Pentax medical was made aware of a complaint on (b)(4) 2017 which stated 'cannot put brush in - blocked' for video gastroscope model eg-2990i/serial (b)(4) received through the pentax medical service department.No other information was provided at the time of the report.The video gastroscope was returned to pentax medical for evaluation.The pentax endoscope technician confirmed a screw stuck inside biopsy inlet port causing blockage in the primary channel.This finding confirmed the customer's complaint.Other inspectional findings included: -dry/wet leak tests failed.-leak at air/water nozzle.Pentax service confirmed the screw was a pentax part.The channel and biopsy barrel needed to be removed from the t-piece to remove the pentax screw.In addition, pentax service stated the pentax screw was somehow dropped into the t-piece during repair and during final assembly, the biopsy barrel was attached trapping the screw.Pentax medical contacted the facility to gather additional information.A response was received from the initial reporter on 27-nov-2017 stating the event occurred on (b)(6) 2017 when the physician became aware of the blockage during the procedure prior to any accessory being utilized.The blockage was discovered when the physician was unable to place biopsy forceps down the channel due to resistance.The gastroscope was removed immediately when the blockage was discovered and sent into pentax for service.No injury or issues occurred with the patient.The facility also confirmed that this was the first time the gastroscope was used for a procedure since received from pentax for a previous repair on 19-oct-2017.In addition, the gastroscope was high level disinfected prior to being used for the first time on (b)(6) 2017.Pentax medical replaced the following components on the video gastroscope involved in the event: -o-rings and seals.-distal end assy with tubes.-adjusting collar.-bending rubber.-distal attaching plate.-segment assy attaching screw.-segment attaching screw.-angle wire.-r/l and u/d pulley assy.-a/w supply tube retaining collar.-rl lock knob retaining nut cover.The video gastroscope was returned to the customer on 20-nov-2017.
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