The customer reports a cluster of five patient (urinary tract) infections following cystoscopy procedures using one of three cysto-nephro videoscopes.During the procedures the user observed foreign bodies shedding from the tips of the scopes.Case with patient identifier (b)(6) reports patient 1 of 5.Case with patient identifier (b)(6) reports patient 2 of 5.Case with patient identifier (b)(6) reports patient 3 of 5 (this report).Case with patient identifier (b)(6) reports patient 4 of 5.Case with patient identifier (b)(6) reports patient 5 of 5.Patient three of five: the procedure performed was a cystoscopy.Eight days following the procedure, a urinary tract infection was diagnosed via urine culture.The microorganism identified in the patient¿s urine was staphylococcus aureus.The patient was treated with an unspecified antibiotic.The patient¿s current condition is reported as ¿recovered¿.No additional consequences to the patient have been reported.The facility does not document which scope was used in the procedure record, so it is unknown which of the three scopes was used in this procedure.There were no scope cultures performed by the facility.The customer declined to allow an olympus endoscopic support specialist (ess) visit to observe reprocessing procedures and provide education to the staff as indicated.The customer declined request for olympus to culture the scopes as part of the investigation.The customer emphasized; we cannot conclusively say that the scopes caused the infections.We observed an increase of infections at the same time we observed foreign bodies shedding from the tips of scopes.The customer uses a sterrad automatic scope reprocessor (aer) for sterilization.Pre-cleaning is performed immediately post-procedure following the manufacturer¿s recommended steps.
|
The customer reports a cluster of five patient (urinary tract) infections following cystoscopy procedures using one of three cysto-nephro videoscopes.During the procedures the user observed foreign bodies shedding from the tips of the scopes.Case with patient identifier (b)(6) reports patient 1 of 5.Case with patient identifier (b)(6) reports patient 2 of 5.Case with patient identifier (b)(6) reports patient 3 of 5 (this report).Case with patient identifier (b)(6) reports patient 4 of 5.Case with patient identifier (b)(6) reports patient 5 of 5.Patient three of five: the procedure performed was a cystoscopy.Eight days following the procedure, a urinary tract infection was diagnosed via urine culture.The microorganism identified in the patient¿s urine was staphylococcus aureus.The patient was treated with an unspecified antibiotic.The patient¿s current condition is reported as ¿recovered¿.No additional consequences to the patient have been reported.The facility does not document which scope was used in the procedure record, so it is unknown which of the three scopes was used in this procedure.There were no scope cultures performed by the facility.The customer declined to allow an olympus endoscopic support specialist (ess) visit to observe reprocessing procedures and provide education to the staff as indicated.The customer declined request for olympus to culture the scopes as part of the investigation.The customer emphasized; we cannot conclusively say that the scopes caused the infections.We observed an increase of infections at the same time we observed foreign bodies shedding from the tips of scopes.The customer uses a sterrad automatic scope reprocessor (aer) for sterilization.Pre-cleaning is performed immediately post-procedure following the manufacturer¿s recommended steps.
|