MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 791-700

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that lithovue touch pc was attempted to be used in the kub during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the lithovue touch pc did not boot up to the boston scientific application automatically; there was a sidewinder application error.The facility had no other devices available to complete the procedure therefore the procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that lithovue touch pc was attempted to be used in the kub during a ureteroscopy procedure performed on (b)(6) 2021.During preparation, the monitor was having sidewinder application error.The monitor did not boot up to bsc application automatically.There were no other lithovue scopes available and reusable scopes were broken.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 3191 is being used to capture aborted/cancelled procedure.Block h10 investigation analysis: the returned lithovue touch pc was analyzed, and a visual evaluation noted that the device showed no damages and the product has passed visual inspection.A functional evaluation noted that the touch pc booted up to a black screen.Since the touch pc booted up to a black screen, the side winder could not be accessed.The reported event was confirmed.This investigation is assigned a most probable conclusion code of cause traced to component failure.This conclusion was selected because the reason for (b)(6) monitor is having side winder issue was most likely determined to be probable component failure from the functional test performed and the analysis of the available information.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that component failure was the most probable cause of the complaint/event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 11653110
• MDR Text Key: 245550291
• Report Number: 3005099803-2021-01657
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729891901
• UDI-Public: 08714729891901
• Combination Product (y/n): N
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: 791-700
• Device Catalogue Number: 791-700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1