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

Model Number CYF-5

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The endoscope was returned to the service center for evaluation.A review of the service history indicated the scope was purchased on (b)(6) 2017 with no previous repair records.The evaluation observed the endoscope failed the leak test and found that the distal bending section cover was torn.In addition, the service group noted the bending section cover glue was cracked and the endoscope produced a stain defect on the image.Based on the report, the likely cause of the reported event was attributed to incorrect reprocessing.

Event Description

The service center was informed that during reprocessing, the endoscope was sterilized without the venting cap.There was no patient involvement reported.

Manufacturer Narrative

There was no contact with a patient as this was a brand new scope that was being reprocessed after the move into a new facility.This scope has not yet been used for a procedure.The endoscope has not yet been manually cleaned.A third party automated endoscope reprocessor (aer) machine (steris vpro serial: (b)(4)) was being used to reprocess the endoscope.There have not been any issues with the aer.The aer is also a brand new machine.The scope was being stored in a third party vpro approved container.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-02364.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause of the reported event such as conducting reprocessing without vent cap, conducting manual cleaning only, and not conducting air flushing after reprocessing are seemingly mishandling by the user (reprocessing personnel).We determined from above that there was deviation from ifu in this case.Impact on mishandling the scope: the operation manual (ifu) alerts on reprocessing conducted without attaching vent cap as follows: sterilization:ethylene oxide (eto) gas sterilization:attach the eto cap to the endoscope connector before sterilizing.If the eto cap is not attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section.Ifu also alerts on conducting manual cleaning only, and not conducting air flushing after reprocessing (incorrect reprocedding) as follows: warnings and cautions:using improperly reprocessed or stored instruments may cause patient cross-contamination and an infection.

• 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: 9996966
• MDR Text Key: 200778439
• Report Number: 8010047-2020-02364
• Device Sequence Number: 1
• Product Code: FAJ
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1