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

Model Number CYF-5

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The olympus representative covered and explained the pre-cleaning, process following olympus guideline on reprocessing with the customer.Additionally, the pre-cleaning in-service included all cleaning, disinfection and sterilization information that is contained in the olympus manual.All models reviewed are listed in the product section.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

During an in-service reprocessing of fiberscope "cyf-5, it was observed a deviation in the scope cleaning process as the customer mentioned they do not do any pre-cleaning on their urology scopes.Customer also does not conduct an extended soak if the scope sits longer than an hour.Issue was noticed during reprocessing training.There was no harm, infection or user injury reported due to the event.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.Updates to section e2, e3, g2, h6 e3 title - "sterile processing manager the legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation presumed that the event was caused by a human error.Additionally, it was confirmed that there are no product-related or manufacturing-related events, and there are no safety issues.As stated on the ifu (instruction for use) as a preventive measure, the user manual states: if the endoscope is not immediately precleaned, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Olympus will continue to monitor field performance of this device.

• 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: 12516613
• MDR Text Key: 272876203
• Report Number: 8010047-2021-12154
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• 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
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1