MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE; FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE

Model Number URF-V3R

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2022

Event Type  Injury  

Manufacturer Narrative

This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00419.The device referenced in this report has not been returned to olympus for evaluation.It is reported to be sequestered at the facility.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

Customer response requested.Per email and included attached medwatch report: "attached please find a medwatch report regarding an issue experienced with on olympus flexible ureteroscope urf-v3r.Patient required an additional surgery and extended hospital stay and is scheduled for a follow-up ureteroscopy in 4 to 6 weeks.The equipment has been sequestered." medwatch: at end of left ureteroscopy, surgeon was removing flexible ureteroscope (scope), it became lodged in ureter.After several attempts to remove the scope, patient was transported to eswl room, after lithotripsy, surgeon got the scope tip down to the mid si joint, but it could not be completely removed.Scope was cut just below the handpiece with trauma shears.Care was taken to keep the amplatz wire in tact.Fluoroscopy revealed the scope to be at midpoint of the si joint and the amplatz wire in the left upper quadrant within the collecting system.A 12 fr catheter was placed alongside the scope.Post-op day 2 patient returned to surgery for removal of scope.After gentle traction and manipulation, the scope was moved below the level of the si joint.Attempt to advance an 11 fr ureteral access sheath over the scope, but resistance was met at left ureterovesical junction and the sheath would not move any further.Rotation of the sheath did not produce texture consistent with retained stone fragment.Fluoro revealed what appeared to be a break in the external sheath of the ureteroscope.A holmium laser was used on fine cut setting and power setting of 0.8j and 20 hz to extend the full incision of the ureterotomy to around 2 cm.Gentle traction was reapplied and the ureteroscope was removed intact.No significant stone debris was noted.Patient will be scheduled for another uteroscopy in 4 to 6 weeks to assess quality of mid-ureter and look for any potentially retained stone fragments.Additional relevant history per medwatch report: 29 yom patient with obstructing left proximal ureteral calculus in excess of 1 cm, per ct, also question of 5mm distal ureteral stone.And refractory colic.History of november 2021 left-sided flank pain.Axial imaging demonstrated 1cm proximal left ureteral calculus.Symptoms resolved after a few days, but patient denies interval passage of stone.Nicotene dependence, unspecified, uncomp.Customer response requested.Et/494864 11may2022.This is a tier 1 complaint due to the reported effect on the patient.Investigation is required.The reporting person, (b)(6), has been contacted to see if the product will be returned to olympus for inspection.The common device name has been updated according to the accessgudid website.Rdb/494539 18 may 2022.Update: olympus rep.(b)(6) reported that the urf-v3 was stuck inside the patient's ureter.The scope was stuck against a stone.The base of the scope was cut off on (b)(6) 2022 and the rest of the scope was removed surgically on (b)(6) 2022.(b)(6) has been identified as a duplicate of (b)(6).The customer name, model number and serial number are a match.(b)(6) will be closed as a duplicate.Iuc code changed from ss to ssw (non-valid complaint).Changed pae q1 from yes to no and q2 to n0 due to this is a duplicate non-valid complaint.Added saleforce # (b)(4) 20may2022.The notification date for the duplicate complaint, (b)(6), was may 08, 2022, so the notification and aware date for this complaint ((b)(6)) have been updated to match.(b)(4) 25 may 2022.

Event Description

Additional information received from the customer: the customer reported the subject device was inspected prior to surgery however the findings were not provided.The intended procedure was not completed.It is unknown if there was a procedural delay due to this malfunction.The patient's hospitalization was extended due to the need for a second procedure due to the malfunction.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer, the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.A4: 56.7 kg.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to patient's anatomy.The instructions for use provide the following warning: if significant resistance is felt during insertion due to an anatomical reason, do not insert, withdraw, or turn the insertion tube of the endoscope with excessive force.If there are official standards on the applicability of endoscopy and endoscopic treatment that are defined by the hospital¿s administrations or other official institutions, such as academic societies on endoscopy, follow those standards.Before starting endoscopy and endoscopic treatment, thoroughly evaluate their properties, purposes, effects, and possible risks (their nature, extent, and probability).Perform endoscopy and endoscopic treatment only when their potential benefits are greater than their risks.Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE
• 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: 14620665
• MDR Text Key: 293462088
• Report Number: 8010047-2022-09550
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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
• Treatment: AMPLATZ WIRE
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White