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 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

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) procedure performed on (b)(6) 2022 for a stent removal.During the insertion, the screen went blank and displayed the scope error screen.Then the scope displayed the loading screen and went to the home screen.The physician raised the scope high above his head and visualization was lost.Then, the controller was restarted and the scope was unplugged from the controller but this did not resolve the issue.The physician then changed to another exalt scope to complete the procedure.There were no patient complications as result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: 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.An image assessment was performed by connecting the device to an exalt controller.Upon connection, no image displayed, only the 5-dot initialization screen, then the display reverted to the exalt splash screen.The umbilicus connector was opened and it was confirmed that the 12-pin interposer was not fully seated in the umbilicus printed circuit board assembly (pcba); the interposer was crooked and the adhesive bond between the interposer and pcba connector had failed.The 12-pin interposer was re-seated into the pcba, the umbilicus housing was closed, and the scope was plugged back into the controller.A clear, live image displayed.The device was articulated in all directions and combinations of directions; no image impact was observed.The reported event was confirmed.Therefore, based on the investigation findings, the probable cause for the reported event was determined to be manufacturing deficiency, which indicates that the failure mode is attributable to the manufacturing process.An investigation to address this problem has been completed.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 an exalt model d single-use duodenoscope was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on jun 03, 2022 for a stent removal.During the insertion, the screen went blank and displayed the scope error screen.Then the scope displayed the loading screen and went to the home screen.The physician raised the scope high above his head and visualization was lost.Then, the controller was restarted and the scope was unplugged from the controller but this did not resolve the issue.The physician then change to another exalt scope to complete the procedure.There were no patient complications as result of this event.

• 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: 14834173
• MDR Text Key: 302345850
• Report Number: 3005099803-2022-03518
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0027666382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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