MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHR

Device Problems Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)

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

Event Date 07/29/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the cysto-nephro videoscope had parts fall off from the distal end (including the bending section cover rubber) and the tip was chipped.The issue was observed during reprocessing and there were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for a device evaluation and the customer¿s allegation was confirmed.In addition to the reported in b5, the device evaluation found the bending section cover rubber glue was cracked, the bending section cover rubber was scratched, and the plastic distal end cover insulation was not to specification; however, these defects are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, the tip was confirmed to be chipped; however, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿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: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17732683
• MDR Text Key: 323226102
• Report Number: 3002808148-2023-09733
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2023

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-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2012
• 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