MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number	URF-V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Entrapment (2327)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report study findings reported in the literature article as well as investigation results.The device(s) referenced in this report have not been returned to olympus for evaluation, therefore physical evaluation of the complaint device could not be performed.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications conclusion: no device malfunction was reported by the authoring physician.The physician attributes the adverse event a rare procedural complication that can occur as a result of treating of large proximal ureteral stones.
Event or Problem Description
It is reported in the literature article titled "between a rock and a hard place: a case report of stone fragment impaction causing a retained ureteroscope requiring open surgical intervention", a patient experienced physical entrapment of the complaint device requiring surgical intervention.As reported in the case study, a (b)(6)-year-old female underwent ureteroscopy for a 2 cm right ureteropelvic junction obstructing stone.After laser lithotripsy, there was significant buildup of stone debris distally along the ureteroscope.Conservative measures failed to remove the ureteroscope.The entrapment of the device is reported to be due to heavy stone burden surrounding the tip of the device preventing it's safe withdrawal.An exploratory laparotomy through a two sides gibson incision and right ureteral dissection for manual removal of the stone debris was performed with eventual removal of the retained ureteroscope.A ureteral reimplant was performed.Postoperative computerized tomography (ct) showed residual hydronephrosis, but there was no obstruction seen on renal lasix scan.There is no report of device malfunction.The study concluded that ureteroscopic treatment of large proximal ureteral stones may lead to the rare complication of ureteroscope retainment caused by stone impaction.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct g2.As a result of confirmation, there are no similar complaints.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11465524
• Report Number: 8010047-2021-03600
• Device Sequence Number: 19740717
• Product Code: FGB
• UDI-Device Identifier: 04953170287183
• UDI-Public: 04953170287183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• 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: 02/15/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female