MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Mechanical Problem (1384)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported to olympus that the uretero-reno videoscope turned off and the screen went black during a procedure.The customer noted that the event occurred 1 hour and 30 minutes into the procedure while the device was being inserted into the access sheath.The device was removed and replaced with a similar device.There were no reports of patient harm associated with the event.During the olympus evaluation of the device, it was noted that there was shaving in the forceps hole.This report is submitted due to the reportable malfunction, identified during the olympus evaluation and in-house service of the device.As the problem was found during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

The device was returned to olympus for repair and the customers allegation was confirmed.The issue occurred due to charge-coupled device damage.It was also noted that water tightness was not maintained and a scratch was seen at the curved rubber adhesive and the operating section.The tube of the insertion part was collapsed and the bending angle was insufficient due to elongation of the angle wire.The indicator of the operating section was detached.It was also noted that the universal cord had scratches and wrinkles.The tip covered had signs of burning.There were also scratches noted in the light guide and video connector cases.The video connector case had dirt that was difficult to remove.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.An investigation of the event could not conclusively identify a root cause of the reportable malfunction.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO 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: 16065170
• MDR Text Key: 308455023
• Report Number: 3002808148-2022-05706
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2022

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: Other
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 61338BX; OTV-S190
• Patient Sex: Female