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

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a lithovue touch pc was intended to be used in a procedure performed on (b)(6) 2022.During preparation, the lithovue touch pc was showing a user message "hardware malfunction" on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Investigation results: a visual inspection of the touch pc few scratches on the pc frame.A red circle with a red bar shows on the screen.Functional test discontinued.Touch panel pc shuts down successfully.It can be concluded that the reported showing a screen crossed out in red was confirmed during investigation.This investigation is assigned a most probable conclusion code of cause traced to component failure.This conclusion was selected because the reason showing a screen crossed out in red was duplicated/replicated during functional testing.The conclusion is acceptable because the analysis of the available information in the complaint did match/reveal the fault condition within the product.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 related was the most probable cause of the complaint/event.

Event Description

It was reported to boston scientific corporation that a lithovue touch pc was intended to be used in a procedure performed on (b)(6) 2022.During preparation, the lithovue touch pc was showing a user message "hardware malfuntion" on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15633487
• MDR Text Key: 306728823
• Report Number: 3005099803-2022-06154
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1