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

Model Number URF-P6

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, water tightness not maintained due to holes in the curved rubber, bending angle insufficient due to elongation of the angle wire, water tightness of the operation part (base of the suction port) not maintained, scratches found on operation part, forceps plug cap scraped off, scratches found on eyepiece, scratches found on grip, scratches found on up/down plate and scratches on diopter ring.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility submitted a repair request to the olympus service center, on uretero-reno fiberscope for leaking at the bending section rubber.Upon inspection and testing of the customer returned device, the scope forceps stopper was found scraped.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the stress of repeated use, external factors, or handling.It is recommended that the user facility inspect the device prior to use and on a regular basis continuously.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15191861
• MDR Text Key: 303816460
• Report Number: 9610595-2022-00713
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1264-2022
• Patient Sequence Number: 1