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Model Number CYF-5
Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/24/2020
Event Type  Injury  
Event Description
The attending physician reported that there were nine patients that were examined by the same cystoscope. After the procedure, the patients' urine samples were cultured and an esbl e. Coli had been recovered on those patients' urine sample. The patients were treated with antibiotic. The cystoscope was returned to olympus for evaluation to see if there had been any damage on the device. According to the physician, some of the patients have had urine retention, hematuria, septic issues, and uti after the procedures, which triggered him to have the patients' urine be cultured. In addition, it was reported that the device has been manually reprocessed and soaked in cidex opa (disinfectant). The user facility further reported that there had been no device culture performed prior to returning the device to olympus. The device was returned to olympus and evaluation is pending, as the device was sent to an off-site laboratory for microbiological testing. As part of our investigation into this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess the user facility¿s reprocessing practices, and provide reprocessing training if necessary. On november 13, 2020 an olympus ess visited the user facility to perform a scope reprocessing and infection control in-service for the staff. The ess covered infection control information referenced in the user manual and reprocessing manual. In addition, the ess requested the facility staff to show him each step in the use and reprocessing of the scope. Based on the ess' observation the facility staff was not currently using correct transport bins, not pre-cleaning, not leak-testing after each case, not currently reprocessing stopcock, not currently replacing saline bag or irrigation tubing between each case, not currently reprocessing reusable brushes, not currently soaking scope in detergent for the recommended amount of time, and not currently properly rinsing scope. The ess communicated these findings to the facility staff, and provided them a list recommended proper reprocessing techniques and proper handling and storage of the device. The ess recommended the use of disposable ancillary equipment and to consider using the gluteraldehyde based disinfectant, such as aldahol 1. 8. This is for patient #5 and this is 5 of 9 reports. Cross-reference related reports: (b)(4).
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key10934608
MDR Text Key219181410
Report Number2951238-2020-00518
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 11/04/2020,12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCYF-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2020
Event Location Hospital
Date Report to Manufacturer11/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1