MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

Patient 5 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 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.The exact event dates are unknown, however, the procedures were in (b)(6).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 (b)(6) 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.The device was not returned to olympus for evaluation and remains at the user facility.The user was offered additional culture testing and eto sterilization at a third party laboratory, however has not responded.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

This report is being supplemented to provide additional information regarding the reported event.Additional information received identified the patient was treated with bactrim antibiotic as an outpatient.Per the customer, the patient is doing fine, recovering at home.The scope will be returned to olympus and the independent laboratory will provide a culture test and eto sterilization.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.

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• 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: 10259812
• MDR Text Key: 198414196
• Report Number: 2951238-2020-00475
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2020,08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention