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

Model Number CYF-5A

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.Upon inspection and testing of the unit, the reported problem of a ¿black dot on the vision¿ was unconfirmed.The angulation control lever became locked, due to corrosion caused by water leakage.In addition, a cut and detached adhesive on the a-rubber, a cut and dented connecting tube, a deformed and discolored distal end, a dented connecting tube, and a deformed venting connector under grip were discovered.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported a ¿black dot in the vision¿ during maintenance on their oes cystonephrofiberscope.Upon inspection and testing of the unit, the angulation control lever became locked.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

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The g2 field was corrected based on information available at the initial report submission.Also, all non-reportable device evaluation findings have been included in this report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the insertion section was damaged by physical stress applied during device handling by the user, therefore water tightness was lost.However, a definitive root cause could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: oes cystonephrofiberscope cyf-5/cyf-5a chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope_ inspection of the bending mechanism.Oes cystonephrofiberscope cyf-5/cyf-5a chapter 7 cleaning, disinfection and sterilization procedures 7.4 leakage testing 7.4 leakage testing.In addition, the following non-reportable malfunctions were found during the device evaluation: the specified resolving power was not obtained due to deformation of the distal end.The distal end also had discoloration.The bending section cannot be fixed firmly due to damage of the forceps elevator.The eyepiece was dirty.Lastly, the control unit had corrosion due to the water 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: 16977620
• MDR Text Key: 315868907
• Report Number: 3002808148-2023-05116
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (y/n): N
• Reporter Country Code: BT
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/06/2023

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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