MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Microbial Contamination of Device (2303); Material Integrity Problem (2978)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the service center for evaluation.The user facility did not provide a specific serial number for the subject; therefore, no review of the instrument history can be performed.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events.If additional information becomes available, this report will be updated and supplemented accordingly.The cyf-vh ¿reprocessing before the first use/reprocessing and storage after use¿ section of the instruction manual warns users after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.¿.

Event Description

The service was informed that six patients contracted salmonella infections in their bladder after undergoing cystoscopy procedures with the facility¿s cysto-nephro videoscope.The user facility¿s physician reported that this has led to sepsis in some of the patients.The bacteria has been tested and found to be the same genetic bug in each case.The user facility has identified 35 additional patients that will need to be notified as they also were in contact the subject scope.All patients were seen at the same clinic.In addition, the physician reported that the scope passed the leak test and appeared in satisfactory condition upon quick visual inspection.The facility performed a closer visual inspection on the subject scope and observed break, separation or perforation along the insertion tube of the scope; where the uppermost point of the bending rubber begins and meets the bending section bending rubber.The scope was then cultured and tested positive for salmonella.This is 5 of 6 reports.

Manufacturer Narrative

This supplemental report is being submitted to report additional information received from the user facility and provide the scope serial number.Additional information received states that the user facility became aware of the infection issues on may 23 and 24 2019.The customer has confirmed that there were 5 infected patients and not 6 infected patients as originally reported.Patient has been identified having salmonella enteritidis urinary tract infection.This scope was cultured using selective broth (selenite) and there was no growth.This scope was reprocessed many times before the customer identified this scope as possible source during their investigation.This scope has been quarantined.Furthermore, the user facility reported that the cystoscopes are leak tested (olympus leak tester), brushed (bw412t olympus), undergo air flushing after the manual cleaning and then sterilized.No issues noted related to any reprocessing equipment regarding errors, alarms, or smoke.The last date of the reprocessing in-service is unknown; however, the facility reports the staff received specific training on this scope.

Manufacturer Narrative

In june 2019, the olympus canada (oci) site requested a clinical nurse to visit the user facility to observe the facility's reprocessing practices.The oci clinical nurse made multiple attempts to schedule an in-service at the user facility; however, to date the facility has not responded.As part of our investigation, the oci clinical nurse reviewed previous service notes for this account.The oci clinical nurse reported visiting the user facility in february 2019 to observe the facility¿s reprocessing practices, provide repair reduction and in-service training.At that time a review of the repair history was performed for the cystoscopes at the user facility, which revealed some care and handling concerns that have persisted since the last olympus endoscope care and handling observational analysis (echoa) done in august 2017.A total of 37 original equipment manufacturer (oem) service repairs (5minor, 5major, 27 refurbishments) have occurred since february 2018.The service history review for the olympus flexible cystoscopes at the user facility revealed that the three most frequent repairs are: a-rubber and a-rubber glue damaged, endoscope leaking, fluid invasion, insertion tube & distal end damage.The most frequent type of damage was preventable damage, and included; a-rubber/bending section damage, insertion tube damage and distal end damage.The preventable damage resulted from repeated stress on the instruments¿ materials during transportation, procedures and reprocessing.Extreme rotation or bending of the insertion tube during procedures puts the insertion tube and bending section under great mechanical stress, which is a predisposition to insertion tube, bending section and angulation mechanism wear and tear.In addition, other factors that may have contributed to flexible cystoscopes repairs over the last year include: over- torquing, bending of the insertion tube and over-coiling of the cystoscope by the physician during procedures.Handling and bending of the insertion tube and coiling of the endoscope in the rigid instrument container by the room staff during set-up and take down.The limited and challenging procedure room space that restricts standard care and handling practices for the flexible cystoscopes.Improper care and handling of the cystoscopes during the reprocessing process.Cystoscope reprocessing inconsistencies with, pre-cleaning, manual cleaning, and sterilization.The (oci) clinical nurse reported that during the reprocessing observation it was noted that the user facility was not performing pre-cleaning of the cystoscopies after the procedure.The clinical nurse provided the user facility the following recommendations to improve the reprocessing and care of the facility¿s cystoscopes: follow the oem recommendations for the pre-procedure inspection on all your cystoscopes.The pre-procedure check should include checking the electrical connector for any residual moisture that may impact the cystoscope image as well as passing an endotherapy device through the biopsy valve to ensure that the accessory extends smoothly from the distal end and to ensure that no foreign objects are lodged in the endoscope instrument channel.Precleaning of flexible endoscopes should be initiated immediately post-procedure at the bedside and be completed in a timely manner.Ensure that the precleaning process is performed as outlined in the olympus reprocessing instruction manual.It is important that all procedure room staff including physicians receive inservicing on the precleaning steps for the cystoscopes as outlined by the manufacturer to ensure proper precleaning is being done.Olympus can provide in-servicing for your procedure room staff.Ensure that the cystoscope angulation locks are in the ¿free¿ position and the stiffening mechanism for the cystoscopes is in the ¿neutral¿ position when the precleaning the endoscope.This will reduce the opportunity for the angulation wires to become stretched, which can limit the physician¿s ability to flex the endoscope during procedures.Contaminated cystoscopes should be transported in a closed container that is leak-proof, puncture resistant, and large enough to contain a loosely coiled endoscope.Ensure that all flexible cystoscopes are safely secured in the transport containers during transport.Damage can result when endoscopes are subjected to rattling, sliding around, or falling during transport.During transport, it is essential for the scope to be loosely coiled in an organized way and for the scope components and tubes to lie flat and separately.Separate cystoscopy accessories from the contaminated endoscope to prevent puncture and penetration damage.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation and laboratory results.The scope was sent to an independent laboratory for microbial testing.The scope's instrument channel port was cultured and no salmonella organism or any other microbial growth was recovered from the scope.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.Olympus performed a visual inspection on the returned scope with an olympus borescope and found no signs of foreign material or stains inside the channel.The scope¿s image was checked and found to be normal.The scope passed leak testing.A review of the instrument history revealed the scope was purchased on july 22, 2014 and was last returned for service was august 30, 2018 requiring a full refurbishment.Based on device evaluation findings, no foreign material was found in the scope¿s channel.The cause of the reported event could not be conclusively determined.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8701939
• MDR Text Key: 148200307
• Report Number: 2951238-2019-00944
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other