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 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device code a06 captures the reportable event of loss of visualization inside the patient.The returned device was visually inspected.No 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.Witness marks were observed on the pads of the umbilicus connector, indicating it was connected to a controller.An image assessment was performed by connecting the device to an exalt controller.Upon connection, a live image was displayed.No issues were observed with the image.Articulation of the tip was performed using the control knobs on the handle, and no changes to the image quality were observed.The tip was manually manipulated, and no issues were observed with the image.The umbilicus was manipulated by rotating the connector at the controller, applying tension to the cable, and stressing the strain reliefs at the connector and the handle.No issues were observed with the image.The handle was opened to visually inspect the repeater button printed circuit board assembly (pcba) at the top of the handle.No visual defects were identified.The scope was unplugged from the controller and plugged into a second controller.Articulation and umbilicus manipulation was repeated, no image issues were observed.The umbilicus connector was opened and the electronic components within were visually inspected.The 12 - pin interposer was firmly seated in the pcba connector, and the interposer and connector were adhered in place.No issues were observed.Product analysis was unable to replicate the failure or identify any issue that could have caused or contributed the reported event.No probable cause could be identified.In addition to potential device defects, issues with the customer setup, controller, or other factors during the attempt to use the device may have contributed to the reported event, as no device issues were identified.Therefore, based on all gathered information, the conclusion code selected for this event is no problem detected.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 was not performed because this investigation did not identify a potential process, design, or manufacturing related issue.No device issues were identified.A labeling review was performed and based on the information provided there was no indication that the device was not used in accordance with the directions for use (dfu).

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-01114 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cholecystitis on (b)(6) 2023.During the ercp procedure using the exalt model d scope, the exalt image was lost.The exalt model d scope was then removed and replaced with a reusable scope that was used to complete the procedure without patient complications.

• Brand Name: EXALT MODEL D SINGLE-USE DUODENOSCOPE
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 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: 16501836
• MDR Text Key: 310952802
• Report Number: 3005099803-2023-01097
• 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
• Report Date: 03/08/2023

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: 0030762627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• 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