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 Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed, a foggy image occurred due to damage on the objective lens.The device evaluation found that the forceps channel port was shaved.Additional findings include the following: the adhesive on the bending section cover had a chip, and the venting connector under the grip was shaved.The following had a scratch: the eyepiece, the diopter ring, the control unit, the grip, the forceps elevator lever, the up / down plate, the angulation lever, and the connecting tube.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

The customer reported to olympus, the uretero-reno fiberscope had a cloudy image.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the forceps channel port was shaved.There were no reports of patient harm.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 investigation and correction to b3.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, the root cause of the shaved lens was caused by stress of repeated use, external factors, or handling.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: 17362412
• MDR Text Key: 319448732
• Report Number: 9610595-2023-10354
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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: 06/20/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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