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

Model Number CYF-VHA

Device Problem Mechanical Jam (2983)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found that water tightness was lost due to a pinhole in the instrument tube, the connecting tube had buckling and dents, the rubber cover of the forceps channel port was detached, the switch box was deformed, the universal cord was dented, up/down plate and universal cord were sticky, the control unit was sticky due to water leakage, the forceps or channel cleaning brush could not be inserted smoothly due to a dent on the instrument tube, the light guide bundle was slipping down, switch #1, #2, and #4 did not work due to corrosion, the label on the light guide connector was peeled, the video connector was deformed, the video connector case was deformed, the video cable coating was peeled, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the cysto-nephro videoscope had no angulation when the control knob was turned.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the bending section could not be controlled at all due to corrosion of the angle mechanism.The report is being submitted due to corrosion of the angle mechanism found during evaluation.

Event Description

Information obtained identifies the device inspected prior to use, and was returned after the cystoscopy procedure was completed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct the initial medwatch with information inadvertently left off (identified via b3 and b5).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, it is likely that the bending part could not be controlled due to the corrosion of the angle mechanism part.There is a possibility of mishandling by the user.The water immersion has occurred in the ud plating, lg bundle, and lg tubing.The event may be prevented by following the instructions for use which state: "-do not flex (less than or equal to 10cm) the soft part of the endoscope, the universal code, and the video cable.Damage may occur.-if the endoscope is dropped or a strong impact is applied to the tip, there may be some damage to the lens even if the tip is not scratched or missing.Discontinue endoscopy and contact olympus.-do not twist or bend the bent part by hand.Damage may occur.-do not make the curvature stronger.The covering of the curved section may stretch or tear, which may cause water leakage.-do not place or press the video connector or light guide connector on the insert during transportation or reprocessing.Damage may occur.-the remote switch of the endoscope cannot be removed from the operating section.Pushing, pulling or twisting with strong force may damage the switch or cause water leakage." 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16384818
• MDR Text Key: 309666053
• Report Number: 3002808148-2023-01468
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• 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
• Report Date: 04/06/2023

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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