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

Model Number URF-V

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the uretero-reno videoscope had a curved tube air leak.There was no patient harm associated with the event.The device was evaluated, and it was found that the forceps plug mouthpiece was scraped.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed due to a pinhole on the connecting tube.In addition to the forceps plug mouthpiece being scraped due to physical stress, additional findings were as follows: due to a pinhole on channel tube, water tightness was lost; due to a chip on distal end, water tightness was lost; due to adhesive peeling between light guide (lg) lens and distal end, water tightness was lost; adhesive on bending section cover had a chip; due to wear of angle wire, bending angle in up direction did not meet standard value; lg bundle had breakage; due to burn on lg bundle, illumination was uneven; electrical contact of video connector had corrosion; and up/down plate had discoloration.The following device components were found to be scratched: video connector case, video connector, lg connector, video cable, universal cord, insertion tube rotation ring, forceps elevator lever (surgical products), angulation lever, grip, scope cover, control unit, and image guide protector.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

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.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to physical stress, external factors, or handling.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17743856
• MDR Text Key: 323378865
• Report Number: 9610595-2023-13333
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2008
• 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