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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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.This event has been reported by the importer on mdr# (b)(4).

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 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 wa23080a.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.

Manufacturer Narrative

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.

Manufacturer Narrative

This report is being supplemented to report the conclusion of the investigation.Updated information in h6.Summary of complaint: customer reports that seven patients (reported in this case and mw reports: 8010047-2020-04157, 8010047-2020-04156, 8010047-2020-04155, 8010047-2020-04159, 8010047-2020-04160, 8010047-2020-04152) developed e.Coli extended spectrum beta-lactamases (esbl) urinary tract infections post cystoscopy procedures during which the endoscope was used.The endoscope had been used on a patient with a known infection of the same microorganism.Review of the product labeling supplied with the scope provides the following instructions related to this issue: 5.2 precautions.All channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.During use, the instrument normally comes in contact with intact mucous membranes.To minimize the risk of transmitting diseases from one patient to another, the endoscope must undergo thorough manual cleaning followed by high-level disinfection or sterilization after each examination.This instruction manual specifies chemicals and endoscope reprocessors for cleaning, high-level disinfection and sterilization which can be used in combination with endoscope, and those chemicals and endoscope reprocessors which cannot be used with endoscope.For those which do not appear in this manual, contact olympus-designated service centers, olympus branches or sales representatives.If inappropriate chemicals or endoscope reprocessors are used, it may accelerate the deterioration of the endoscope and may cause come-off of parts and adverse event on patients¿ health.For the usage of these chemicals and endoscope reprocessor, follow the instruction manuals of those.Olympus does not assure the effect of cleaning, disinfection and sterilization.Contact the manufacturers of those chemicals and endoscope reprocessor.If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization.A review of the device history record (dhr) was performed, and it was confirmed that the actual product was shipped in a normal condition and conformed to all specifications.The complaint device was not returned to olympus for physical evaluation/culturing despite three requests, however, an olympus endoscopy support specialist did go to the facility and observe the entire sterilization process being performed at the facility with the following observations: (1) stopcock is not being reprocessed after each procedure.(2) the scope is not being immediately pre-cleaned at the bedside.(3) proper waterproofing inspections are not being performed (not performing with the scope completely submerged).(4) the syringe used when cleaning is not the correct size (using a 60ml syringe instead of a 30ml syringe as instructed in the scopes instructions for use).It was determined that the cause of these events is related to improper handling of the device by the user(s) (failing to follow the instructions for use related to proper re-processing of the scope).The facility was given a full reprocessing in-service, with corrections and recommendation to switch to automated endoscope reprocessor (aer) for standardization.The facility stated that they have shut down all cases until an aer is in the facility and the staff has finished competency training with the infection prevention team.

• 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: 10260476
• MDR Text Key: 205583657
• Report Number: 8010047-2020-04158
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention