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 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Impact code: (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 could not recognize the flexscope and was showing boot to desktop 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 h10: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned lithovue touch pc was analyzed, and a visual evaluation noted that the touch pc showed some scratches on the pc frame and the back panel.A functional evaluation noted that unit completed 3 power off/on cycles and the unit booted to desktop windows screen every time.Continued testing by double clicking the sidewinder application to run the program.The scope was plugged in, and the touch pc was connected to the external monitor, after scope was initialized the touch pc showed a clear live image absent of any undesirable artifacts on both screens.This test was done three times.The touch pc showed a clear live image every time.The touch pc was left running for over two hours.No other issues with the device were noted.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 boot to desktop issue was confirmed during functional testing.The conclusion is acceptable because the analysis of the available information in the complaint did find/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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

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 could not recognize the flexscope and was showing boot to desktop 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; attn: return products; st. paul MN 55112
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13802916
• MDR Text Key: 288106491
• Report Number: 3005099803-2022-01442
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729891901
• UDI-Public: 08714729891901
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1