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

Model Number M0067913500

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the scope was functionally tested prior to disinfection and it did not initialize, a live image was not displayed and the screen displayed a hardware malfunction.A visual assessment was performed after decontamination and found the scope active deflection section was kinked near the distal end.A functional evaluation was performed after disinfection and also found that the device did not initialize and a live image was not displayed.Additionally, damage was identified on the working channel and light was visible from the outside of the scope¿s active deflective section where a hole was located.The hole went completely through one wall of the scope.The handle was disassembled to expose the handle printed circuit board (pcb).Corrosion was present on components within the handle most likely due to fluids leaking into the device as a result of the hole in the scope.The evaluation concluded that based on the evidence present during the evaluation and the information provided within the complaint record, that the deflection section kink was most likely due operational or anatomical aspects of the procedure.Therefore, the most probable root cause for the kinked shaft is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a lithovue single-use digital flexible ureteroscope was used during a retrograde intrarenal surgery (rirs) procedure of the left kidney performed on (b)(6) 2016 according to the complainant, during the procedure when using a non bsc reusable laser fiber, the laser fiber broke and fired within the inner channel of the lithovue scope creating two holes in the scope.Reportedly, the physician was unaware that the laser fiber broke and continued to use the laser in an extreme bent deflection position for more that 30 minutes.As a result the internal light of the scope no longer functioned and the image was lost.The procedure was completed with a reusable scope.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; deflection section of the scope kinked.

• 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: 5628325
• MDR Text Key: 44841853
• Report Number: 3005099803-2016-01244
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2016

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: 10/31/2016
• Device Model Number: M0067913500
• Device Lot Number: 18552089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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