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 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the 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 in the stomach on (b)(6) 2021.It was reported that the patient was in the prone position for this procedure.During the procedure, when the physician entered the stomach and retroflexed the scope to look for varices, the exalt scope lost visualization.It was reported that a gray screen with 3 dots appeared, followed by the ercp scope error screen.The procedure was completed with a second exalt scope.There were no patient complications reported as a result of this event.

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 in the stomach on (b)(6) 2021.It was reported that the patient was in the prone position for this procedure.During the procedure, when the physician entered the stomach and retroflexed the scope to look for varices, the exalt scope lost visualization.It was reported that a gray screen with 3 dots appeared, followed by the ercp scope error screen.The procedure was completed with a second exalt scope.There were no patient complications reported as a 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 exalt model d single-use duodenoscope was analyzed, and a visual evaluation noted that there was no evidence of any damage or defect 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 exalt scope to an exalt controller.Upon connection, a live image was displayed.No problems were observed with the image.Articulation of the tip was performed using the control knobs on the handle, and the image would become disrupted when the tip was articulated in the left direction.The screen would display five dots as the controller was attempting to reestablish the image signal, and the scope error screen would display.The unit was disconnected, the tip was straightened, and the device was reconnected to the controller; a live image was displayed until the tip was articulated in the left direction.The handle was opened to visually inspect the interposer connectors and electronics.The interposers were fully seated in position, and had no adhesive wicking into the connectors.The interposer in the umbilicus was visually inspected and was found to be fully seated in position, with no adhesive wicking into the connector.X-ray inspection of the camera wire was conducted and it was noted that the wire was twisted.The device was disassembled and the camera wire was visually inspected.It was noted that the tape surrounding the wire had kinks present.The camera wire was disassembled, and the wires within the tape were visually inspected.It was noted that there was epoxy from the camera overmold process in between the wires, and the camera image wire was tightly twisted.The camera image wire was inspected using x-ray, and it was noted that the wire shield was damaged.Finally, the camera image wire was disassembled and the wires within were visually inspected.It was noted that the shield was damaged, exposing the internal conductors.Product analysis confirmed that the device would lose visualization when the scope was articulated, and found that damage to the distal camera wire resulted in a short between the camera image signal conductor and the wire braid.Therefore, the reported event was confirmed.Based on all available information, the conclusion code selected for this event is manufacturing deficiency.An investigation to address this problem is in progress.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 directions for use (dfu) / 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
• MDR Report Key: 11697081
• MDR Text Key: 247726869
• Report Number: 3005099803-2021-01625
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: 08714729993605
• Combination Product (y/n): N
• PMA/PMN Number: K193202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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: 11/17/2022
• Device Model Number: M00542421
• Device Catalogue Number: 42421
• Device Lot Number: 0026376983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1