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

Model Number	URF-V3
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Laceration(s) (1946); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an elective kidney stone surgery, a rigid cystoscope was used to look into the bladder, followed by a short rigid ureterscope.The ureteroscope was removed and an access sheath was inserted followed by the subject device.The kidney stone was found and lasered for approximately 2 minutes using a laser fibre.Following this, a retrieval basket was inserted to remove the stone from the ureter.Upon trying to remove the subject device it was noted that there was a lot resistance and the subject device was not coming out of the ureter.The retrieval basket was removed from the patient.The access was both removed from the ureter/urethra.X-ray was used to see if there was anything obvious blocking the subject device from coming out of the ureter.The surgeon re-entered the bladder using a cystoscope in order to see from the inside what was happening.When in the bladder looking at the subject device in the ureter it was noted silver (metal) could be seen near the flexible bending section of the tip where the black rubber bending section would usually be.The surgeon was unable to remove the subject device without tearing and taking part of the ureter with the scope.A 5fr stent was placed in the patient, along with a 16fr 2-way catheter.When the ureteroscope was removed from the patient, the surgeon used a pair of scissors to cut the ureter off of it.The procedure was delayed approximately 30 minutes.Post procedure, it was noted that the black protective sheath had been damaged approximately 5cm from the tip and had been pushed up or bunched up towards the tip of the ureteroscope, making it thicker causing it to get stuck in the ureter.A cut was noted in the lining.The patient was reviewed in recovery and due to bleeding the 2-way catheter was exchanged with a 3-way so that irrigation could be used.The patient was in the hospital for one extra night and the physician he would likely have the stent in for 6 weeks; he will then have another procedure to see if the ureter has healed itself.If it has not, the patient may have to have a surgery to reimplant the ureter.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) further investigation.The device was evaluated by olympus, and the metal part of the insertion section was observed to be exposed.Although the observed defects are non reportable malfunctions, the damaged device led to the reported adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the reported adverse event was likely due to the following: during handling of the device by the user, the bending section was damaged, and the device could not be removed from the ureter.As a result, part of the ureter had to be removed, and the procedure was delayed.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿inspection of the endoscope¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO VIDEOSCOPE
• 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: 20174539
• Report Number: 9610595-2024-17988
• Device Sequence Number: 20593151
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/12 X 35CM ACCESS SHEATH - COOK MEDICAL; 270MICRON HOLMIUM LASER FIBRE (UNKNOWN); N-GAGE BASKET - COOK MEDICAL; RIGID CYSTOSCOPE (UNKNOWN MANUFACTURER); SHORT RIGID URETERSOCOPE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male