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

Model Number URF-V

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation, service repair noted the reported issue of "broken working channel" was not confirmed, however, evaluation found deformed distal end.Bending section glue adhesive found separated.Control rotation knob found broken.M case connector found cracked.Plug unit found cracked.No image due to broken video cable.Water and air leakage due to perforation of curved part of the a-rubber.Damage to second bend due to physical load observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

The demo device found with broken (deformed) working channel , (blocked channel) was reported.The issue found during demonstration.There was no patient involvement on this reported event.No harm reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the deformation of the instrument channel port was unable to be identified.The following is included in the instructions for use: ¿warning: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.¿.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• 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: 16608219
• MDR Text Key: 312408717
• Report Number: 9610595-2023-04969
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2024

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: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 04/15/2023; 05/14/2024
• Supplement Dates FDA Received: 06/06/2023; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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