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

Model Number CYF-5

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus, however, the device evaluation has not been completed.Upon completion of the investigation, a supplemental report will be submitted.

Event Description

A user facility reported to olympus that while removing the stopcock for cleaning, the entire port came out of the scope.The problem, as reported to olympus, was identified during reprocessing.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the legal manufacturer's investigation, it is likely there was an external force applied to the a-rubber, which caused it to become dislodged.In addition, the t-tube mounting cap (instrument channel port) was also subject to external force when attaching or detaching the t-tube (forceps / irrigation plug), which likely resulted in damage (loosening and/or deformation).It is also confirmed that the device was manufactured more than 4 years ago, which use over time could lead to aging deterioration.

• 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
• MDR Report Key: 11345734
• MDR Text Key: 232587782
• Report Number: 8010047-2021-02845
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1