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

Model Number URF-P7

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Event Description

A user facility reported to olympus air leak at the tip of uretero-reno fiberscope.There were no reports of patient or user harm.The device was returned, and olympus repair center identified the forceps channel port is shaved.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation of the returned device.

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During evaluation, the customer's initial report of an air leak at the tip was confirmed.Due to a dent on the distal end and peeling adhesive between the objective lens and distal end, water tightness is lost.The following additional findings were also noted: crack on the control unit, chipped adhesive on the bending section cover, and assorted scratches.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, a definitive root cause could not be determined.A review of the device history record confirmed the following repairs were made on january 31, 2023: distal end view cloudy- replaced.[the suggested items from the sc].Control section connector cover cracked- replaced.Although a definitive root cause could not be determined, we presumed that the event occurred by stress of repeated use, external factors or handling of the device.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17343613
• MDR Text Key: 320171731
• Report Number: 9610595-2023-10251
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• 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
• Report Date: 07/18/2023

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-P7
• Device Catalogue Number: N5781844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/18/2023
• Date Device Manufactured: 03/24/2020
• 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