MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL D SINGLE-USE DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0054242CE1

Device Problem Optical Problem (3001)

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

Event Date 02/04/2023

Event Type  malfunction  

Manufacturer Narrative

Device code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was introduced for use in an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2023 for treatment of stones.During procedure, after 60 seconds of using the device, the scope lost visualization, and an error screen was displayed.The controller was re-booted and the scope was re-connected, but the issue was not resolved.The scope was then removed from the patient.The procedure was completed with another exalt model d scope.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was introduced for use in an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2023 for treatment of stones.During procedure, after 60 seconds of using the device, the scope lost visualization, and an error screen was displayed.The controller was re-booted and the scope was re-connected, but the issue was not resolved.The scope was then removed from the patient.The procedure was completed with another exalt model d scope.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: upon receipt of this scope at our quality assurance laboratory, the exalt model d single use duodenoscope was thoroughly analyzed.Visual examination did not identify evidence of any damage or defect was observed on the shaft or tip of the device.No fogging or condensation was noted on or in the lens.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.Articulation of the tip was performed using the control knobs on the handle.When the scope was articulated up, both with the led off and on, the live image and led at the distal end of the scope began flashing on and off, showing a live screen and then a black screen or the five dot initialization screen, repeatedly.The reported event was confirmed.When the scope was articulated back to neutral, the image and led became on and steady.The scope was unplugged and the electrical connections from the umbilicus pads were tested using a calibrated digital multimeter in continuity mode.It was confirmed that the led was continuous.The handle was opened to visually inspect the repeated button printed circuit board (pcba) at the top of the handle, and the grounding components in the bottom of the handle.No visual defects were identified.Electrical testing of the repeater button pcba was performed, and it was identified that with the scope in a straight configuration, the device operates as expected; however, with the scope articulated up, the resistance did not perform within specifications, indicating an open on one or both of the camera signal low voltage differential signaling (lvds) wires.The distal end of the scope was visualized under x-ray.No wire damage or kinks were observed at the distal end of the device.The protective wraps were removed from the distal camera cable and wires within were visually inspected; no defects were identified, and no glue was observed wicking proximal to the distal tip.The distal tip of the device was cut off of the camera wires and the twin-ax camera wire was stripped on the proximal and distal ends of the cable to test for continuity of the lvds wires within.The red lvds wire was found to be continuous; the white lvds wire was found to be discontinuous.The discontinuity in the white lvds wire was likely in the location where the white wire broke during disassembly.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on all gathered information, boston scientific complaint investigation determined the probable cause of the reported event was determined to be cause traced to component failure, which indicates that the issues are traced to expected or random failure of a device component.During product analysis, the reported failure mode was replicated as image issues were observed when the scope was articulated up.Additionally, it was confirmed that the device passed all image and articulation testing during manufacturing.The white lvds wire issue may have occurred as a raw material or due to supplier manufacturing, bsc manufacturing, or manipulation of the device during use.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16462130
• MDR Text Key: 310638320
• Report Number: 3005099803-2023-01088
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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
• Device Model Number: M0054242CE1
• Device Catalogue Number: 4242CE
• Device Lot Number: 0030712562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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