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

Model Number CYF-3

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled "residual moisture and waterborne pathogens inside flexible endoscopes: evidence from a multisite study of endoscope drying effectiveness," 22 different model scopes tested positive for microorganisms after reprocessing.Background: endoscopy-associated infection transmission is frequently linked to inadequate reprocessing.Residual organic material and moisture may foster biofilm development inside endoscopes.This study evaluated the effectiveness of endoscope drying and storage methods and assessed associations between retained moisture and contamination.Methods: endoscope reprocessing, drying, and storage practices were assessed at 3 hospitals.Researchers performed visual examinations and tests to detect fluid and contamination on patient-ready endoscopes.Results: fluid was detected in 22 of 45 (49%) endoscopes.Prevalence of moisture varied significantly by site (5%; 83%; 85%; p <.001).High adenosine triphosphate levels were found in 22% of endoscopes, and microbial growth was detected in 71% of endoscopes.Stenotrophomonas maltophilia, citrobacter freundii, and lecanicillium lecanii/verticillium dahliae were found.Retained fluid was associated with significantly higher adenosine triphosphate levels (p <.01).Reprocessing and drying practices conformed with guidelines at 1 site and were substandard at 2 sites.Damaged endoscopes were in use at all sites.Conclusions: inadequate reprocessing and insufficient drying contributed to retained fluid and contamination found during this multisite study.More effective methods of endoscope reprocessing, drying, and maintenance are needed to prevent the retention of fluid, organic material, and bioburden that could cause patient illness or injury.Case with patient identifier (b)(6) reports model urf-p6.Case with patient identifier (b)(6) reports model lf-2.Case with patient identifier (b)(6) reports model lf-gp.Case with patient identifier (b)(6) reports model cyf-3.Case with patient identifier (b)(6) reports model tjf-140f.Case with patient identifier (b)(6) reports model gif-h180.Case with patient identifier (b)(6) reports model gif-q180.Case with patient identifier (b)(6) reports model pcf-h180al.Case with patient identifier (b)(6) reports model pcf-h190dl.Case with patient identifier (b)(6) reports model pcf-q180al.Case with patient identifier (b)(6) reports model gif-h180.Case with patient identifier (b)(6) reports model cf-h180al.Case with patient identifier (b)(6) reports model tjf-160f.Case with patient identifier (b)(6) reports model bf-p190.Case with patient identifier (b)(6) reports model uc-180f.Case with patient identifier (b)(6) reports model gif-hq190.Case with patient identifier (b)(6) reports model cf-hq190l.Case with patient identifier (b)(6) reports model tjf-q180v.Case with patient identifier (b)(6) reports model jf-140f.Case with patient identifier (b)(6) reports model gf-ue160.Case with patient identifier (b)(6) reports model gf-ue160-al5.Case with patient identifier (b)(6) reports model bf-1th190.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The serial number is unknown.Therefore, the manufacturing device history record could not be reviewed.However, only devices that have passed inspection are shipped.The literature reported the result of the microbiological test using olympus endoscope (cystofiberscope) and non-olympus endoscope.As a result of the microbiological testing, microbes were detected from the subject device.There was no report of infection on this literature.The exact cause of the reported event could not be conclusively determined because the subject device was not returned for evaluation.Olympus will continue to monitor field performance.

• Brand Name: OES CYSTOFIBERSCOPE
• 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: 11775819
• MDR Text Key: 276593006
• Report Number: 8010047-2021-05842
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170292323
• UDI-Public: 04953170292323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1