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

Model Number CYF-5

Device Problem Material Separation (1562)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation the user report was confirmed, the valve of the device was missing.Additionally, fluid inside the eyepiece cover glass, and no image was noted.As a result of this refurbishment, the endoscope has been restored to olympus original factory specifications.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The customer reported the biopsy valve fell off of an olympus fiberscope.Additional event and outcome questions have been requested from the initial reporter, but not yet received.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿prior to storage, detach all removable parts from the endoscope.¿ based on the results of the investigation, it is believed that external force applied to the device caused the reported failure.When disconnecting/connecting the t-plug to the mounting connecter, extra forces could have caused damage and loosening of the connector, leading to the reported event.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information was received on14jul2021 from the customer noting that they had a second scope experience the same failure (captured under patient identifier (b)(6) ).However, the customer did confirm that this event did not occur during a procedure, it happened prior to pre-cleaning.The procedure that it was intended for was completed without any patient impact/harm.

• 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: 12159922
• MDR Text Key: 261280025
• Report Number: 8010047-2021-08812
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1