MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION S CYRUS ACMI FLEXIBLE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number DUR-8 ULTRA 007

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 06/10/2015

Event Type  Injury  

Event Description

Right ureter, urinary issues, on (b)(6) 2015, (b)(6) presented to (b)(6) hospital, for removal of a 1.5 cm kidney stone in his right proximal to mid ureter by dr.(b)(6), who elected to perform a right ureteroscopy, laser lithotripsy and stent placement procedure.Dr.(b)(6) inserted a 21 french cystoscope sheath with a 12 inch lens through (b)(6) urethra and into his bladder.A 5 french open-ended catheter was then inserted through the right ureteral orifice, and a super stiff guidewire was passed into (b)(6) renal pelvis proximal to the stones.A semirigid ureteroscope was assembled and inserted to the level of the stones, but due to angulation, dr.(b)(6) exchanged this scope for a dual lumen introducer and inserted a second super stiff guidewire into (b)(6) renal pelvis.Dr.(b)(6) next inserted an olympus dur-8 flexible ureteroscope to the level of the stone, which was then fragmented using a 365u laser fiber.While attempting to fragment the stone, dr.(b)(6) fired the laser inside olympus dur-8 flexible ureteroscope multiple times causing extensive damage to the scope and its bending mechanism.The damage to the scope was so extensive that it no longer functioned properly.After fragmenting the stone and extensively damaging the scope, dr.(b)(6) inserted the scope further to evaluate the right kidney for possible stone fragments.After completion of the procedure dr.(b)(6) felt resistance as he attempted to withdraw the olympus dur-8 flexible ureteroscope from (b)(6) body.The resistance was caused by the extensive damage caused by misfiring the laser inside the scope.Dr.(b)(6) pulled even harder on the olympus dur-8 flexible ureteroscope as he continued in his attempt to withdraw it from (b)(6) body, and it became apparent the scope could not be removed with the application of normal levels of force.Instead, dr.(b)(6) elected to continue to try to remove the scope by applying ever increasing force and pressure to the device to withdraw it from (b)(6) body, eventually causing the scope to disintegrate into multiple pieces while still in (b)(6) body.Dr.(b)(6) was eventually able to withdraw a portion of the olympus dur-8 flexible ureteroscope but 4 cm of the tip, along with numerous fragments of the scope, were left behind in (b)(6) right ureter.Dr.(b)(6) then made multiple attempts to advance a different ureteroscope into the distal ureter and to grasp the largest fragment of the olympus dur-8 flexible ureteroscope in order to extract it, but he was unable to remove any significant portion of the device.Dr.(b)(6) then placed a resectoscope with a collin's knife and unroofed the intramural portion of the ureter, but he was still unable to grasp the remaining fragments of the olympus dur-8 ureterscope.Eventually, dr.(b)(6) lost access to the portion of the olympus dur-8 flexible ureteroscope that was stuck in (b)(6) ureter and could not further unroof the bladder.Dr.(b)(6) then elected to perform an exploratory laparotomy to attempt to remove the fragments of the olympus dur-8 flexible ureteroscope that remained in (b)(6) right ureter.Using a pfannenstiel incision to expose the rectus muscle and fascia, dr.(b)(6) dissected into the retropubic space and right retroperitoneum to reach the right ureter.Then, dr.(b)(6) used a scalpel to open the ureter and remove the olympus dur-8 flexible ureteroscope fragments.He placed a double j stent into the ureter before closing.Ultimately, (b)(6) ureter became obstructed and infected, and he subsequently required multiple surgeries and procedures to repair the damage caused.As of january 24, 2020, olympus america inc., service center had completed a visual inspection of the scope, but has failed to produce any evaluation or report, despite multiple requests.The scope was sent to the below address, receipt of the subject scope by olympus was confirmed, and it is believed that the subject scope remains at the below address in olympus possession and control.Olympus america inc., (b)(4).Fda safety report id # (b)(4).

• Brand Name: S CYRUS ACMI FLEXIBLE URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 9947818
• MDR Text Key: 187398623
• Report Number: MW5094090
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUR-8 ULTRA 007
• Device Catalogue Number: 17723-007
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 97