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

Model Number URF-V3R

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2022

Event Type  Injury  

Event Description

The customer reported in a voluntary medwatch report, at the end of a left ureteroscopy using a flexible uretero-reno videoscope, the scope became lodged in the ureter.The indication for the procedure was obstructing left proximal ureteral calculus in excess of 1cm and per computerized tomography (ct), also a question of 5mm distal ureteral stone and refractory renal colic.After several attempts to remove the scope, patient was transported to extracorporeal shockwave lithotripsy (eswl) room, after lithotripsy, surgeon got the scope tip down to the mid sacroiliac (si) joint, but it could not be completely removed.The scope was cut just below the handpiece with trauma shears.Care was taken to keep the amplatz wire intact.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.On post-op day two, the patient returned to surgery for removal of scope.After gentle traction and manipulation, the scope was moved below the level of the si joint.An attempt was made 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.Fluoroscopy 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 ureterostomy to around 2 cm.Gentle traction was reapplied and the ureteroscope was removed intact.No significant stone debris was noted.The patient will be scheduled for another ureteroscopy in 4 to 6 weeks to assess quality of mid-ureter and look for any potentially retained stone fragments.The patient¿s symptoms resolved after a few days, but the patient denies interval passage of stone.No further consequences to the patient have been reported.

• 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
• MDR Report Key: 14620782
• MDR Text Key: 293615851
• Report Number: 2951238-2022-00419
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403392
• UDI-Public: 04953170403392
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2022,06/07/2022

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
• 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?: Yes
• Distributor Facility Aware Date: 05/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZ WIRE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 57 KG