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

Model Number CYF-5R

Device Problem Device Reprocessing Problem (1091)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.29jun2021, an olympus endoscopic support specialist (ess) completed virtual in-service regarding cleaning and care of urology scopes.The ess covered infection control information referenced in the user manual and reprocessing manual.The customer stated they manually high level disinfects (hld) their scopes with aldahol.The ess explained to customer that they should follow the aldahol ifu for specific instructions for hld.It was discovered the facility was not previously precleaning their scope, or leak-testing their scopes after each use (they were not previously submerging the scope for leak-testing -using hand-held leak-tester).This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports two patient infections after a diagnostic cystoscopy using an oes cystonephrofiberscope.This case reports patient two of two : an unknown period after a diagnostic cystoscopy using an oes cystonephrofiberscope (for the indication of microscopic hematuria), the patient developed a urinary tract infection.This was diagnosed on an unknown date at an urgent care facility.The patient was treated with an unspecified antibiotic and the symptoms resolved.The scope was not cultured by the facility.Patient one of two is reported in case with patient identifier (b)(6).

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.A review of the instructions for use (ifu) shipped with the device provided the customer with the following chapters of instructions, that if followed properly, could have potentially prevented the reported event: chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Conclusion: we were unable to identify a definitive root cause.We cannot determine, but we presume the following.This phenomenon might have occurred because the device with a remaining fungus was used for a patient.We have already confirmed that the subject device met its standards when it was shipped and that the re-processing procedure of the subject device was inappropriate, so the cause of the remaining fungus did not seem to be the device.The re-processing procedure performed by the facility was inappropriate.We, therefore, surmised that a fungus remained because the device was not fully cleaned.

Manufacturer Narrative

The relationship between the device and patient infection could not be identified.The facility has not conducted a culture test for the equipment.Since the equipment was not returned to olympus, the culture test and equipment inspection could not be carried out.Inappropriate reprocesses such as bedside cleaning after each procedure and non-leakage test were performed at the facility.The instruction manual for the device cyf-5 describes the reprocess method in the following items.By observing this, we think that the indicated event can be prevented.¦chapter 6 compatible reprocessing methods and chemical agents ¦chapter 7 cleaning, disinfection, and sterilization procedures three attempts were performed to obtain additional information, but no response was received from the customer.

• 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: 12165459
• MDR Text Key: 261438493
• Report Number: 8010047-2021-08851
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411182
• UDI-Public: 04953170411182
• 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: User Facility,Company Representative
• 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: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 97 KG