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

Model Number M00542421

Device Problem Optical Problem (3001)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): impact code a06 captures the reportable event of loss of visualization during a procedure.

Event Description

Note: this manufacturer report pertains to one of two used devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-03552 for the exalt model d scope and manufacturer report number 3005099803-2023-03574 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2023.During the procedure, the device was used successfully for most of the case however, at a certain point, visualization was lost and the exalt error message popped up signaling a loose connection of scope's umbilicus cord to the exalt model d controller.Visualization was regained by manually holding the umbilicus connector to the controller in place for the remainder of the case to prevent further loss of visualization.The procedure was completed without any patient complications with the original exalt scope.

Event Description

It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2023.During the procedure, the device was used successfully for most of the case however, at a certain point, the exalt error message popped up signaling an issue with the umbilicus cord being looser than usual.The procedure was successfully completed by holding the controller in place for the remainder of the case.The procedure was completed without any patient complications.

Manufacturer Narrative

Block h6 (device codes): impact code a06 captures the reportable event of loss of visualization during a procedure.Block h10: a visual assessment of the returned device was performed.No damage or defects were noted with the umbilicus connector and witness marks were present; the distal end showed no issues with the elevator or working channel and irrigation lumen exits and the lens showed no issues; residue was seen on the epoxy surface but none inside the lens.An image assessment for visualization was performed.Upon plugging the device into the controller, a live image was displayed.Articulation of the device was performed using the steering wheels at the handle; no issues were noted with articulation.During articulation, the live image would cut out and instead the initialization screen (characterized by 5-dots) appeared.It was determined that moving the umbilicus would cause the image to be lost, specifically tilting the umbilicus up and down.The screen eventually displayed the scope not connected image.The reported event was confirmed.The scope was unplugged and the continuity of electrical connections from the umbilicus pads were testing using a digital multimeter.It was determined that the electrical connection was not continuous.The scope was reinserted into the controller to verify if image issues were present and an image with an inadequate color scheme was displayed.The handle of the scope was opened to inspect the electrical components and no visual defects were seen with the interposer connections or the camera wires in the handle.An x-ray assessment was performed on the umbilicus and no issues were found with the cable wires or the umbilicus board.The scope was plugged in again and a live image was displayed.The movement of cables connected to the repeater button were moved causing the live image to be disrupted.An x-ray assessment was performed on the interposer cables at the handle and a potential break/kink was noted on the camera cable connected to the j5 interposer.Camera wire damage was also noted.With all the available information, boston scientific concludes that the probable cause of the reported event was determined to be cause traced to component failure, which indicates that the problems were traced to an expected or random component failure, specifically, a broken camera wire.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.

• 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: 17249575
• MDR Text Key: 318922608
• Report Number: 3005099803-2023-03552
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

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: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0031313633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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