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

Model Number CYF-5

Device Problems Component Missing (2306); Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated at olympus rrc (regional repair center) prerov service site.The device was received and found with missing ks-mouthpiece and the k- mouth was observed to be deformed.Furthermore, bending section a-rubber glue was found chipped.Connecting tube was squeezed.Control unit was corroded, heavy play and the eyepiece lens were observed foggy.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, defects of the universal cord/distal end/ connector/control section/related parts were reported.Device return evaluation found device ks-mouthpiece is missing.There was no patient involvement associated on this reported event.No user injury reported.

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.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It has been confirmed that this phenomenon does not occur due to product or manufacturing, and there is no problem with safety.(there is no multiple occurrence).Based on the results of the investigation, it was presumed that the phenomenon reported was due to an excessive external force was applied when attaching and detaching the t-shaped tube (forceps / irrigation plug) to the t-shaped tube attachment port (instrument channel port).As stated on the ifu (instruction for use) the user manual states: chapter 9 storage 9.1 storage ¿ prior to storage, detach all removable parts from the endoscope.Olympus will continue to monitor complaints for this device.

• 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: 12611429
• MDR Text Key: 276378406
• Report Number: 8010047-2021-13016
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411182
• UDI-Public: 04953170411182
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 09/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1