MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5A

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the oes cystonephrofiberscope had the rubber gasket at the base of the forceps plug rise, causing intermittent air flow.The issue was found during reprocessing with the procedure being completed.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: the forceps mouthpiece was dislodged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the forceps mouthpiece was dislodged.The following non-reportable malfunctions were found during the device evaluation: there was insufficient curvature angle, forceps insertion and insertion of cleaning brush.There were flaws in the adhesion of the curved rubber, scratches on the actuator, grip, air vent, eyepiece and fixing ring.The eyepiece was leaking liquid, the image guide bundle had a stain, the light guide mounting clasp was rattling, the actuator was corroded and leaking grip liquid.The up down plate was leaking liquid.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b3 of the initial medwatch.The information was inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to physical stress.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's re-evaluation of the subject device and findings.There were no significant breakage traces, such as a pit or a defect on the forceps plug hole.And the adhesion of the forceps plug rubber packing was peeled off.Therefore, it is possible, that the stress was applied to the forceps plug hole when the t-shaped tube was detached from the forceps plug hole.Resulting in the rubber packing at the root of the forceps plug being raised and detaching the forceps plug hole.It is likely, that the forceps cap was damaged, so water tightness could not be maintained.Resulting in air leakage.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18097491
• MDR Text Key: 328499899
• Report Number: 3002808148-2023-12499
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

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: Other
• Device Model Number: CYF-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 12/15/2023
• Supplement Dates FDA Received: 11/28/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1