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

Model Number CYF-VHA

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the cysto-nephro videoscope had a suspected water leak.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: due to a cut on the angle wire, the bending section could not be controlled at all.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

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device evaluation found: due to a cut on the connecting tube, water tightness was lost.Due to a pinhole on the channel tube, water tightness was lost.Due to a cut on the angle wire, the bending section could not be controlled at all.The adhesive on the bending section cover had a chip.Due to slipping down of the light guide bundle, narrow band imaging observation image was not bright enough.Due to discoloration of the light guide bundle, illumination was uneven.Due to slipping out /down of the light guide bundle, illumination was poor.Due to damage on the channel tube, the channel cleaning brush and forceps could not be inserted smoothly.The video connector case had a scratch.The video connector had a scratch.The light guide connector had a scratch.The video cable had a scratch.The forceps elevator, lock engagement lever (sp) had a scratch.The angulation lever had a scratch.The universal cord had a scratch.The up/down angulation lever plate had a scratch and was sticky.The grip had a scratch.The switch box had a scratch.The suction cover had a scratch.The control unit had a scratch.The direction of the rubber cover of the forceps channel port was different.The universal cord was sticky.The grip was sticky.The connecting tube had a wrinkle and a dent.Due to damage on the bending tube, the joint section between bending the tube and distal end was not secured.The control unit had corrosion due to water leakage.The investigation was ongoing.A supplemental report will be submitted upon completion of the investigation.

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 4 years since the subject device was manufactured.Based on the results of the investigation, the root cause could not be determined.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: 17903739
• MDR Text Key: 325263199
• Report Number: 3002808148-2023-10994
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• 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: 10/10/2023

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: 09/14/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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