MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

Patient Problems Bacterial Infection (1735); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558)

Event Date 08/27/2020

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#8 and this is 8 of 9 reports.Cross-reference related reports: (b)(4).

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10934591
• MDR Text Key: 219182973
• Report Number: 2951238-2020-00521
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411144
• UDI-Public: 04953170411144
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• 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 Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 65