On (b)(6) 2014, fujifilm medical systems u.
(fmsu) was contacted by (b)(6) hospital and advised on fujinon (note: fmsu's endoscopes bear the brand name of "fujinon") duodenoscopes and patients testing positive for cre (carbapenem-resistant enterobacteriaceae).
Fujifilm medical systems u.
(fmsu) immediately initiated an investigation, including a visit to (b)(6), to identify the root cause for the incident.
Fmsu personnel were informed that, in response to cre incidents at its sister hospital, (b)(6) had conducted a review of prior medical records for its patient who were positive for cre.
At the time of this report, fmsu has been advised that two of three endoscopes ((b)(4)) have allegedly been cultured positive for cre.
Three patient who had undergone ercp procedures tested positive for cre and two of three of these patients expressed symptoms consistent with positive cre.
The customer is unsure whether the patient transferred cre to the endoscope or vice versa.
Non-fujifilm equipment, including a channel cleaning device instead of cleaning brush, is used to manually clean the endoscopes and an aer is used for automated high-level disinfection.
A review of fmsu service records for (b)(6) indicated no abnormalities other than general wear and tear repairs attributable to normal usage and handling of the device.
Fmsu has requested but has not received any information on any treatment or hospitalizations for these patients, at the time of this initial report.
In addition, fmsu has requested that the duodenoscopes that tested positive for cre be returned for a detailed examination.
To date, the customer has not returned any duodenoscopes to fmsu.
The investigation is still ongoing.
Fmsu will submit a supplemental mdr once the investigation is completed.