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 Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The scope is in use at the facility.The subject device was not returned to the service center for evaluation.The cause of the improper reprocessing cannot be determined at this time.As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.To date, the ess visit has not been finalized.In addition, the customer was provided the delayed scope reprocessing letter via email.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

The customer reported that a delay in reprocessing occurred as the scope was left unclean and reprocessed the next day in the automatic endoscope reprocessor (aer).No other reprocessing step were performed prior to the scope being placed in the aer.The customer reported that the scope was being put into service.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the cause is likely human error.This issue is addressed in the instructions for use (ifu): "oes cystonephrofiberscope cyf-5/cyf-5a chapter 7 cleaning, disinfection and sterilization procedures 7.3 precleaning preclean the endoscope at the bedside in the procedure room immediately following the procedure.When using the cyf-5, these steps are to be performed when the light source is turned off.When using the cyf-5a, the steps are to be performed when the suction pump is turned on and still connected to the endoscope.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 the 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: 12338861
• MDR Text Key: 267920451
• Report Number: 8010047-2021-10427
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1