MAUDE Adverse Event Report: STRYKER URT-7000S; FLEXIBLE URETERSCOPE

Model Number 0501110111

Device Problems Difficult to Remove (1528); Sticking (1597); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem Tissue Damage (2104)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Pt had ureteroscopy for bilateral stones.After completion of the left side.We proceeded to address the ureteral stones on the right side.The procedure seemed to go smoothly, although at some point the resident operating the scope did feel some laxity in the control of the flexible scope, no obvious damage was observed and we proceeded to treat the stone.When resident attempted to withdraw the scope, there was resistance at the distal ureter.The scope would move in a retrograde direction back towards the kidney, but would not move past a certain point in the antegrade direction.We attempted to advance the access sheath over the scope to bring the scope into the sheath, but it would not advance.I proceeded to again attempt to withdraw the scope with steady pressure.At this point the scope was felt to release and was able to be withdrawn.Visual inspection of the scope revealed the outer plastic coating and underlying wires had broken and allowed them to bunch or accordion at the distal few centimeters of the scope, which led to the scope becoming lodged in the distal ureter.Visual inspection of the bladder revealed an intussuscepted right ureter within the bladder, which is a result of a ureteral avulsion.Upon confirmation of the diagnosis with retrograde urethrography and ureteroscopy, decision was made to proceed to an open reconstruction to fix the avulsion.The patient's family was updated and consent was obtained.Pt was moved to a room that was appropriate for open surgery and a right ureteral reimplantation was performed without further complication.Reason for use: using stryker scopes as a trial for 2 month period.

• Brand Name: URT-7000S
• Type of Device: FLEXIBLE URETERSCOPE
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3748403
• MDR Text Key: 4414496
• Report Number: MW5035587
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2014

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: 0501110111
• Other Device ID Number: 502110111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR