[97904506]
Fujifilm medical systems u. S. A. , inc. (fmsu) was informed on october 25, 2017 by a service partner that a hospital had experienced several pseudomonas infections in their respiratory department and the doctors were concerned they could be from endoscopes, although the source of the infection had not been determined. Fujifilm attempted to contact the hospital at that time, but the hospital did not respond to the inquiry. On december 12, 2017, fmsu was informed by a service partner that the hospital had used the endoscope (eb530t serial (b)(4)) to obtain patient bal samples which resulted in positive pseudomonas cultures. The first instance of the subject endoscope scope bal sample resulting positive occurred on (b)(6) 2017. During the (b)(6) episode the endoscope was subsequently tested for contaminants and resulted positive for pseudomonas. The subject endoscope was then sent to a fujifilm authorized service facility for inspection and repair. The service facility completed the repair and returned the scope to the hospital on november 29, 2017. The endoscope was reprocessed and on (b)(6) 2017, was used and resulted in positive patient bal samples for pseudomonas. Although positive pseudomonas cultures were found to be associated with the subject endoscope, there are no reports of patient infections or of there being any adverse outcomes in patients undergoing bronchoscopy procedures with the subject endoscope. The endoscope was segregated and removed from use as soon as the hospital staff became aware of the positive cultures, during both instances. On (b)(6) 2017, after the second positive culture results were obtained, the hospital staff sent the endoscope to the fmsu service facility for additional inspection/evaluation by fujifilm. The endoscope is currently undergoing service and repair. Upon conclusion of the investigation, additional information will be reported in a follow up report.
Patient Sequence No: 1, Text Type: D, B5