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

Model Number 791-360

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 12/20/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used in a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, the lithovue flexscope was used and a hardware malfunction user message appeared on the screen.The patient had already received the maximum dose of propofol and the anesthesiologist did not authorize repeating the procedure on the same day.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

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.(b)(4).

Event Description

It was reported to boston scientific corporation that a lithovue flexscope was used in a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, the lithovue flexscope was used and a hardware malfunction user message appeared on the screen.The patient had already received the maximum dose of propofol and the anesthesiologist did not authorize repeating the procedure on the same day.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 h6: medical device problem code a27 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.

Manufacturer Narrative

Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted procedure outcome.Block h10: investigation results: the returned lithovue flexscope was connected to the monitor, there was no live image displayed.A visual inspection of the umbilicus connector observed damage or rounding of the connector key, indicating misaligned connection.The umbilicus was replaced, and the problem persisted.There was no evidence of fluid ingress in the handle, damage to the camera assembly or the camera wire.The connector key was observed to have damage or rounding, indicating misaligned connection to the lithovue workstation.Component signal tracing was performed on the printed circuit board assembly pcba and identified a bad component.The reported event was confirmed.Product analysis discovered the device was unable to display a live image due to a faulty component on the pcba caused by the damaged connector key.An investigation to address this issue is in progress.Based on the information gathered, the investigation conclusion code selected is failure to follow instructions, which indicates problems traced to the user not following the manufacturers instructions, resulting in the damaged connector pins, due to the misaligned connection of the flexscope connector to the workstation receptacle.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 flexscope was used in a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, the lithovue flexscope was used and a hardware malfunction user message appeared on the screen.The patient had already received the maximum dose of propofol and the anesthesiologist did not authorize repeating the procedure on the same day.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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13191809
• MDR Text Key: 283616698
• Report Number: 3005099803-2022-00040
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 05/16/2022

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 Expiration Date: 04/27/2023
• Device Model Number: 791-360
• Device Catalogue Number: 791-360
• Device Lot Number: 0027216766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/20/2021; 04/20/2022
• Supplement Dates FDA Received: 01/18/2022; 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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
• Patient Sex: Male