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Model Number CYF-5
Device Problems Problem with Sterilization (1596); Microbial Contamination of Device (2303)
Patient Problem Urinary Tract Infection (2120)
Event Type  Injury  
Event Description
Patient 9 of 9: it was reported during an in-service at the facility that nine patients have developed e. Coli extended spectrum beta-lactamases (esbl) urinary tract infections post cystoscopy procedures during which the endoscope was used. The endoscope was not sampled or cultured. When cultured, the microorganisms e. Coli esbl were detected among the patients. Per the user facility, the patient information will not be provided. Copies of the test results are not available. The endoscope was used on a patient with a known infection of the same microorganism. The scope was reprocessed immediately following each procedure. The scope was not ethylene oxide (eto) sterilized. The patient was treated with bactrim antibiotic as an outpatient. Per the customer, the patient is doing fine, recovering at home. The endoscopy support specialist went over all cleaning processes with the facility and observed the stopcock was not being reprocessed, there was no pre-cleaning in the procedure room, the scope was not being fully submerged during leak testing, the correct size syringe was not being used during manual cleaning (using 60ml syringe instead of 30ml), the scope does not have sufficient rest time in enzymatic detergent, and was not fully submerged in the high level disinfectant (hld). The user facility was not flushing hld into scope before hld rest time. It was also noted that during the ess evaluation, it was observed the facility was not using aspiration scope (cyf-5a) but using cyf-5r. Additionally, the facility was not using an mb-155 leak tester. Also, the facility was not using a lint-free cloth. The exact event dates are unknown, however, the procedures were in april-may. There were no other devices involved in the event. There was no delay in the procedure. The intended procedure was completed with the same device. Per the customer, the cleaning and disinfectant solutions used with the endoscope were cleaning detergent powercon triple enzyme detergent and high-level disinfectant (hld): revitalox resert. The minimum effective concentration is being checked with every cleaning procedure. The endoscope channel is being brushed during manual cleaning with a disposable olympus bw-411b brush. There was a slight delay in the pre-cleaning being performed immediately after a procedure as the scope was moving to the scope cleaning area. The process has been changed to pre-clean the scope in the procedure room immediately following the procedure. The endoscopes are being leak tested prior to manual cleaning. The leak tester being used is an olympus (b)(4). The customer reported there have not been any issues noted with the leak tester or automated endoscope reprocessor (aer). The last reprocessing in-service was provided on december 16, 2018. There has been a change in the reprocessing personnel. Since this time, there has been one additional reprocessing staff member who was competency checked by the facility staff. All reprocessing personnel are trained on how to properly reprocess an endoscope. The scope is being stored in a designated scope cabinet with no loops and not touching the perimeter of the cabinet. A conclusion is not yet available as results are pending completion of the investigation.
Event Description
This report is being supplemented to provide additional information and corrected data regarding the reported event. Additional information received from the customer clarified this event involves seven patients and not nine as previously reported as two of the listed cases were cultures that were collected prior to the procedure. Therefore, this importer report is no longer reportable. Please reference the importer report #s below for patients 1 through 7 respectively: 2951238-2020-00471; 2951238-2020-00472; 2951238-2020-00473; 2951238-2020-00474; 2951238-2020-00475; 2951238-2020-00477; 2951238-2020-00476.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key10328336
MDR Text Key200570903
Report Number2951238-2020-00483
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/31/2020,08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/02/2020
Event Location Hospital
Date Report to Manufacturer07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/27/2020 Patient Sequence Number: 1