The product evaluation concluded the following: shaft has over bends next to strain relief.Monocoil to vertebrae welding break.Multiple scrape marks inside channel with bump, no leak found.Voids around spread lens and ccd window with debris.Chipped spread lens.Debris at handle housing and at hand grip surface.Kinked umbilical cord.Broken light fibers inside handle housing and at vertebrae system.Debris at angle cover surface.The evidence produced from this investigation suggests that user error can be linked to the physical state of the instrument.The documented scope damage could be a contributory factor towards patient infection.In order to perform a microbiological assessment of the video cysto urethroscope (11272vnu, s/n (b)(4)), it was sampled by flushing all channels and the outer surfaces with process water.The samples were submitted to (b)(4) laboratories to specifically determine if p.Aeruginosa was present.The final report from (b)(4) laboratories confirmed that the organism in question (p.Aeruginosa) was not present in the samples analyzed.
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Allegedly, the doctor performed a cystoscopy procedure on a patient.Post procedure, the patient went to the er and was found to have dysuria.Urine culture of patient confirmed pseudomonas aeruginosa infection.He was treated with a ceftazidine iv and is responding well to antibiotics.There were 3 patients infected; this report is for patient #1.
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