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

Model Number CYF-5

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the oes cystonephrofiberscope had a silver piece that the irrigation plug connects to that unscrews and removes when the irrigation plug is removed, and that this occurs even when screwed in tight or loose.The issue was found during preparation for use for a diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer's allegation was confirmed; the endoscopy mouthpiece was out of place.The additional evaluation findings are as follows: the instrument channel had a leak, the plastic distal end cover had stains, the objective lens had a stain, the light guide lens had a stain, the image was not visible due to liquid inside the eyepiece section there was evidence of a third party insertion tube, bending section cover and bending section cover glue.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.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 stress.The event can be prevented by following the instructions for use (ifu) which state: caution ¿ do not pull the universal cord and video cable 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 coil the insertion tube, universal cord, or video cable with a diameter of less than 10 cm.Equipment damage may result.¿ do not attempt to bend or twist the endoscope¿¿¿s insertion section with excessive force.The insertion section may be damaged.¿ do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end.Visual abnormalities may result.¿ if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found.In this case, stop using the endoscope, and contact olympus.¿ 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 cause water leaks.¿ do not put or press the video connector and light guide connector on the insertion section when transporting or reprocessing.The insertion section may be damaged.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: 17369849
• MDR Text Key: 319489627
• Report Number: 3002808148-2023-07344
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2006
• 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