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

Model Number URF-P6R

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the bending section having a hole/cut and leaking, additional findings were as follows: the image guide was broken on image and back focus was off; loose/broken wire was sticking out of bending section; and angulation was low.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that the uretero-reno fiberscope had the air/water leakages test fail.The event occurred during reprocessing.There was no patient harm associated with the event.The device was evaluated, and it was found that the bending section had a hole/cut and was leaking.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The g2 field was corrected based on information available at the time of the initial submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 5 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established, however, it is likely that physical stress was applied to the bending section.The event can be prevented by following the instructions for use which state: - inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.- 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: 17743915
• MDR Text Key: 323379646
• Report Number: 9610595-2023-13334
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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