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

Model Number URF-P7

Device Problem Problem with Sterilization (1596)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Information provide for the customer reprocessing: customer performs in-channel brushing.Cleaning and disinfection with is performed with an olympus oer-4 automatic endoscopy reprocessor.Sterrad sterility is used.The device has been returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.

Event Description

As reported for this event, during preparation for use a brown liquid flowed out from the tip of the device when device was removed from the sterility pack.There is no harm to any patient.The intended procedure was completed with a similar device.There was a suspicion that the forceps channel had a pinhole.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the subject device was returned to an olympus service center for evaluation.During inspection and testing, service was not able to confirm the customer's reported issue regarding brown liquid flowing out from the tip of the device.There was no brown liquid or dry residue on the distal end or the instrument channel.Service did confirm there was an air leak at the forceps outlet due to a pinhole in the instrument channel.When the instrument channel was checked, there was a piece hanging inside, which was caused by scratching within approximately 10mm from the distal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, although it was confirmed that there was an air leak in the instrument channel, the root cause of how the suggested liquid came out could not be determined.It is possible that the liquid that leaked out of the pinhole of the instrument channel temporarily flowed out of the pinhole of the instrument channel to the forceps outlet.In addition to the pinhole in the forceps channel, service found the bending angle was insufficient due to elongation of the angle wire.Per the legal manufacturer, this issue has no potential to cause or contribute to death or serious injury if the malfunction was to recur.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: 15041637
• MDR Text Key: 298039793
• Report Number: 9610595-2022-00054
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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