The customer reports after routine cystoscopy procedures using the same visera cysto-nephro videoscope, three patients developed urinary tract infections (the customer originally reported two patients, then later reported a third patient).Case with patient identifier (b)(6) reports the first patient case with patient identifier (b)(6) reports the second patient case with patient identifier (b)(6) reports the third patient for this report: four days after the cystoscopy procedure, the patient developed dysuria and fever.A patient urine sample was cultured and was positive for e.Coli.The patient was treated with antibiotics.The patient¿s current condition is reported as ¿improved¿.The patient had no pertinent health history.The customer reported the endoscope was not sampled and cultured; however later stated that symptoms triggered the device sampling and culturing (no results provided).The customer stated that the device was used on a patient with known infection of the same microorganism.The customer suspects that the device is the cause of the patient infections.It is unknown what other factors may be contributory to this reported event.Environmental factors are not being investigated.No genetic testing about bacteria was detected from the endoscope and the patient.The positive urine culture was detected 29apr2022.The device was taken out of service 02may2022.The device was not used between the date of detection and isolation of the device.
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