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

Model Number URF-P7

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was unable to be confirmed.During the device evaluation it was observed that there was a foreign body in the mouth of the forceps due to insufficient cleaning or handling of the scope.Lastly, scratches were observed on the following unit components due to physical stress caused by a handling problem: eyepiece and on the angulation lever.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the uretero-reno fiberscope had a laser probe insertion failure.There was no patient/user harm or injury reported due to the event.Upon device return and evaluation, it was observed that there was a foreign body in the mouth of the forceps which, is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Event Description

During a follow up, the customer confirmed that the issue was discovered during reprocessing of the scope.

Manufacturer Narrative

During a follow up, the customer confirmed that the issue was discovered during reprocessing of the scope.Due to the nature of this reportable event, the customer also provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer cleaned, disinfected, and sterilized the equipment prior to requesting repair.It was unknown if the facility delayed the start of precleaning on the equipment after use.During the precleaning process, it was unknown if the customer supplies air and water through the instrument/suction channel.The customer confirmed that the facility immersed the endoscope in detergent solution.It was unknown if the facility wiped/brushed the instrument channel outlet with a clean lint-free cloth, brush or sponge.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, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.A definitive root cause cannot be determined.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: 19217414
• MDR Text Key: 341525218
• Report Number: 9610595-2024-08953
• 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: 05/28/2024

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: Other
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1