MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V"; URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and a foreign instrument blocked the biopsy channel.The biopsy channel was leaking, the distal end cover was damaged, the bending section glue was chipped, and the insertion part of the bending section cover was worn.The connecting tube and parts of the control unit (grip unit, up/down plate and lever unit) were scratched.The universal cord was scratched and wrinkled.The video cord and scope connector were both scratched.The device also failed the angle inspection.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, there was an air/ water or aspiration issue observed on the videoscope prior to an unknown procedure.During the inspection of the returned device, a foreign instrument blocked the biopsy channel, which had been attributed to insufficient cleaning.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 legal manufacturer's investigation and based on the air leak from the biopsy channel, it was determined that a foreign material was likely clogged inside the biopsy channel possibly due to the device being improperly cleaned.However, there was no detailed information on the foreign material and image, hence, the cause of the issue could not be specifically identified.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "URF-V"
• 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: 12887893
• MDR Text Key: 283849971
• Report Number: 8010047-2021-15208
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: 10/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2011
• 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