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

Model Number URF-P7

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the returned device confirmed the customer allegation.Due to a pinhole on channel-tube, water tightness was lost.Distal end had a burn.Due to wear of angle wire, bending angle in upward direction does not meet the standard value.Due to a dent on channel tube, forceps and the channel cleaning brush could not be inserted smoothly.Eyepiece had a crack.Bending tube was damaged.Forceps channel port was dirty.Venting connector under grip had corrosion.Image guide bundle had significant breakages and had a scratch.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, the uretero-reno fiberscope exhibited leakage.The device was returned and an evaluation at the repair center revealed, the forceps cap was chipped.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There were no reports of patient harm associated with the event.

Event Description

The customer confirmed the device was inspected before use.There was no delay and the procedure was completed.The event date occurred on an unknown day around the middle of december 2022.The procedure was a therapeutic tul (transurethral ureterolithotripsy).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information obtained (identified within b5).Based on the results of the investigation, it is likely that the event was caused by stress of repeated use, external factors, or handling of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event my be prevented by following the instructions for use which state: "inspect the eyepiece section and appearance of the control section for excessive scratching, deformation, loose parts, or other irregularities visually and with touching." 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16305186
• MDR Text Key: 309555857
• Report Number: 9610595-2023-01824
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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