MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V3

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

Olympus (omsc) was informed that the asset/loaner uretero-reno videoscope was returned for service/repair for a reported brush insertion failure due to cleaning.Upon inspecting and testing, foreign matter came out from the distal tip due to breakage to the forceps channel.No death, injury or harm was reported to olympus.

Manufacturer Narrative

The service evaluation confirmed the customer¿s reported issue; as there was clogging inside the forceps channel.The foreign matter was identified as it came out from the distal tip due to breakage to the forceps channel.Additionally, the scope failed the air/water test due to chipping of the distal tip cover.The angulations are below standard specifications due to a stretched angle wire.Also there are cosmetic scratches on the following: the rotation mechanism, on the grip, the angle lever, the video cable, the video connector and casing, the light guide connector, the surface of the light guide coverglass.The investigation is ongoing.Therefore; the root cause of the reported issue cannot be determined at this time.If additional information becomes available a follow up medical device report will be supplemented accordingly.

Manufacturer Narrative

The aware date should be 09-mar-2022.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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to insufficient reprocessing or handling.It is recommended that the user facility receive instruction/reinstruction regarding the method of handling of the device regarding usage environment.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14061543
• MDR Text Key: 298512430
• Report Number: 8010047-2022-06011
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• 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: 08/05/2022

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: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 07/09/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• 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