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

Model Number URF-P6

Device Problem Material Integrity Problem (2978)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the uretero-reno fiberscope exhibited the bending section damaged.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely the event occurred due to stress applied to bending section during device handling.The event can be detected by following the instructions for use: user can detect the suggested event by handling device in accordance with the following ifu.Operation manual_ inspection of the endoscope inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.The event can be prevented by following the instructions for use: operartion manual_ operation_ precautions_ caution - do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.- do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.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: 19055334
• MDR Text Key: 339594971
• Report Number: 9610595-2024-07174
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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