MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0067913500

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The exact age of the patient is unknown however it was reported the patient was over 18 years old.The scope working length did demonstrate signs of use.There was a burn hole on the scope shaft at the distal end; the mark was consistent with laser contact.The device was functionally tested on the lithovue touch pc; it did initialize and display a live image.Pixilation was not observed.The device would not articulate in either direction; the lever would not move.The handle was tapped; no issues were identified with the live image.Using a syringe, air was injected into the working channel luer with the open luer and distal end blocked; a leak was observed.The working channel would not hold a vacuum.Water was injected through the working channel with the open luer and distal end blocked; leak was observed coming out of the burn hole.The handle halves were disassembled to evaluate the components inside the handle.Corrosion was observed inside the handle.No issues were identified with the flex strip connection to the pcb j3.The condition of the returned unit was not consistent with the complaint incident that there was poor image quality; however, evidence present on the returned device indicates the failure mode likely occurred.The defects identified were likely due to being contacted by laser.The directions for use states, ¿do not withdraw a laser fiber back into the ureteroscope while the laser is firing.Doing so may cause patient injury and/or scope damage.¿ it is possible the pixilation occurred due to the interaction with the laser.Therefore, the most probable root cause for the complaint is user/use error.A review of the device history record (dhr) was performed; no anomalies were noted.

Event Description

It was reported to boston scientific corporation that a lithovue standard deflection ureteroscope was used during a ureteroscopy procedure performed in the kidney on (b)(6) 2016.According to the complainant, during the procedure, blue and multi-color pixilations on the monitor appeared intermittently.It was reported that when using the laser, the physician lasered through the distal end of the scope causing the image issue.The procedure was completed with a new lithovue standard deflection ureteroscope.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.This event has been deemed a reportable event based on the investigation results; articulation lock-up.

• Brand Name: LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6047459
• MDR Text Key: 58072230
• Report Number: 3005099803-2016-03209
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2016

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 Expiration Date: 04/30/2018
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Device Lot Number: 19126544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1