MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00542430

Device Problems Device Sensing Problem (2917); Optical Problem (3001); Unexpected Shutdown (4019)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6) hospital.(b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-07080 for the exalt model d scope.It was reported to boston scientific corporation that an exalt model d scope and exalt model d controller were during an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6) 2023.About 20 to 30 minutes into the procedure, the scope's image went dark, then bright, and then returned to normal.A balloon was inserted into the scope in preparation for lithotripsy of the stone.About two minutes into dilation, the screen went black resulting in a loss of visualization.The exalt controller then unexpectedly shut down.The scope was unplugged and the controller was rebooted multiple times but the scope would not turn back on.The accessories and scope were then removed under fluoroscopy and the procedure was successfully completed using a reusable scope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: additional information was received stating that the exalt model d controller has been tested since the event and is functioning as intended.As there is no reportable allegation against the exalt model d controller itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-07080 for the exalt model d scope.It was reported to boston scientific corporation that an exalt model d scope and exalt model d controller were during an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6) 2023.About 20 to 30 minutes into the procedure, the scope's image went dark, then bright, and then returned to normal.A balloon was inserted into the scope in preparation for lithotripsy of the stone.About two minutes into dilation, the screen went black resulting in a loss of visualization.The exalt controller then unexpectedly shut down.The scope was unplugged and the controller was rebooted multiple times but the scope would not turn back on.The accessories and scope were then removed under fluoroscopy and the procedure was successfully completed using a reusable scope.There were no patient complications reported as a result of this event.Additional information received on january 4, 2024 - the exalt model d controller has been tested since the event and is functioning as intended.

• Brand Name: EXALT CONTROLLER
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18474543
• MDR Text Key: 332431242
• Report Number: 3005099803-2023-07081
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: 08714729990901
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542430
• Device Catalogue Number: 4243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1