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

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed following information from the user facility.There was an outbreak of pseudomonas aeruginosa infections associated with cystoscopies performed at the user facility urology outpatient clinic.As a result of microbiological testing by the user facility, the same microbes (pseudomonas aeruginosa) as the causative microbes of the reported infections were detected from the sample collected from each of four cystoscopes (cyf-5: serial number (b)(4), cyf-5: serial number (b)(4), cyf-5: serial number (b)(4), and cyf-5: serial number (b)(4)).The user facility performed cystoscopies using these four cystoscopes on (b)(6).The user facility did not provide other detailed information such as the number of microbes.These four cystoscopes had been manually reprocessed using peracetic acid, and reprocessed with a non-olympus automated endoscope reprocessor, sterado.The user facility performed the microbiological test of sample collected from the examination room where the procedures had been performed and no bacteria was detected.The user facility performed additional microbiological tests and no bacteria was detected from the sample collected from each of these four cystoscopes, and the cystoscopes were sterilized.There were no reports on the number of infected patients, their current health condition, or correspondence between the reported infections and the device serial numbers at this time.This report is 3 of 4, and regarding cyf-5: serial number (b)(4).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) obtained the following additional information from the user facility: number of patients infected and current condition: as of (b)(6) 2021, six cases of urinary tract infection after cystoscopy procedures using cystoscopes (cyf-5) had been identified as follows: five patients with pseudomonas aeruginosa infection (four of these patients required hospitalization/ two presented bacteremia/ one required intensive care).One patient with a proteus mirabilis infection required hospitalization (possible endogenous patient flora).There were no deaths resulting from the infections.All patients had been discharged from hospital.Correspondence between infected patients and cystoscope.The correspondence between infected patients and used cystoscopes (cyf-5) was as follows: three cases of infection without knowledge of the used cystoscope (two procedures performed on (b)(6); one procedure performed on (b)(6)).One case of pseudomonas aeruginosa infection after using serial number (b)(4).The procedure performed on (b)(6).One case of pseudomonas aeruginosa infection after using serial number (b)(4).The procedure performed on (b)(6).One case of proteus mirabilis infection after using serial number (b)(4).The procedure performed on (b)(6).Microbiological test results: the results of microbiological tests performed by the user facility on used cystoscopes were as follows: tests performed on (b)(6) before cystoscopy procedures: serial number (b)(4): pseudomonas aeruginosa, serial number (b)(4): pseudomonas aeruginosa, serial number (b)(4): no microbes were detected, and these cystoscopes were sterilized.· tests performed on may 3 before cystoscopy procedures: serial number (b)(4): stenotrophomonas maltophilia, serial number (b)(4): pseudomona aeruginosa and pseudomonas luteola, serial number (b)(4): stenotrophomonas maltophilia, serial number (b)(4): no microbes were detected, and these cystoscopes were sterilized.Tests performed on (b)(6): all cyf-5 used by the user facility (serial number (b)(4)): no microbes were detected, and these cystoscopes were sterilized.Tests performed on (b)(6): serial number (b)(4): no microbes were detected, and this cystoscope was sterilized.Others: the user facility had been used an olympus irrigation plug maj-891.The subject device has not been returned to any of olympus locations.Therefore.Olympus could not investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus europa (b)(4), omsc surmised that the reported event was caused by the use of the subject device with bacterial residue to patients.And, since there was no abnormality in the dhr of the subject device and the validity of the reprocessing methods of the subject device at the user was confirmed, it was surmised that the cause of the bacterial residue was not attributed to the subject device.In addition, microbes were detected in the second microbiological test performed by the user facility, but no microbes were detected in the first and third microbiological tests.Therefore, it was surmised that microbes remained due to insufficient reprocessing, because there was possibility that reprocess according to the instruction manual had not been sufficiently performed by the user facility.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This mdr is being submitted as a result of a complaint retrospective review.Please see updates to a1 and h5.Correction to b2 to add hospitalization.Correction to g2 to add the foreign country portugal.The facility provided their cleaning, disinfection and sterilization (cds) practices of the subject device where the detergent used for pre-cleaning is enzymatic (cidezyme).The device is manually processed with an unknown model olympus cleaning brush, korsolex paa disinfectant, and enzymatic (cidezyme) detergent.The instrument and suction channels are brushed back and forth (3) strokes until no debris is observed in the bristles of the brush.The device is immersed in the disinfectant for 15 minutes.A sterado automated endoscope reprocessor (aer) is used with "standard" detergent and disinfectant.Based on the legal manufacturer's final investigation, a root cause could not be determined.The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11911069
• MDR Text Key: 262174259
• Report Number: 8010047-2021-06926
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization