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

Model Number CYF-5

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

It was reported, the cystonephrofiberscope had slit on the outer sheath.The issue occurred during the reprocessing of the device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to handling of the device - however, this could not be further specified.The instructions for use (ifu) contain the following which is deemed pertinent to the suggested phenomenon: caution: do not pull the universal cord during an examination.The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible.Do not pull the video cable during an examination.The endoscopic image may not be visible anymore.Do not attempt to bend the endoscope¿s insertion tube with excessive force.Otherwise, the insertion tube may be damaged.Do not coil the insertion tube, universal cord or video cable into a diameter of less than 10 cm.Equipment damage can result.Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break, and it may cause water leaks.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on additional legal manufacturer's final investigation and device evaluation.Please see updates to d9, h3, and h6.The device was returned to olympus for inspection, and the customer's reportable malfunction was not confirmed.The root cause of the reported event could not be determined.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: 18658485
• MDR Text Key: 336076877
• Report Number: 3002808148-2024-01169
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 05/14/2024
• Supplement Dates FDA Received: 03/20/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1262-2022
• Patient Sequence Number: 1