MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS DIGITAL CONTROLLER; LED LIGHT SOURCE

Model Number M0054665Z0

Device Problem Poor Quality Image (1408)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the hepatic duct on (b)(6) 2023.During the procedure, when the spyscope was plugged into the controller, nothing changed, it would not go past the screen with the image of the device and did not get to the screen with the dots.It was also reported that the light control buttons did not light up.They tried to unplug, reboot, and used different outlet.However, the controller was not detecting the two scopes.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spy ds controller was analyzed, front panel shows wear.Y/c video outputs worn.Top cover has scratches.Light engine led's have failed.Light engine replacement/upgrade required to repair this controller.The problem was verified according to product analysis.The complaint was confirmed.Based on all gathered information, the conclusion code selected for this event is cause traced to component failure, which indicates that problems are expected or random component failure without any design or manufacturing issue.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 a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the hepatic duct on (b)(6), 2023.During the procedure, when the spyscope was plugged into the controller, nothing changed, it would not go past the screen with the image of the device and did not get to the screen with the dots.It was also reported that the light control buttons did not light up.They tried to unplug, reboot, and used different outlet.However, the controller was not detecting the two scopes.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• Type of Device: LED LIGHT SOURCE
• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17599491
• MDR Text Key: 321724480
• Report Number: 3005099803-2023-04352
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• 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: 09/19/2023

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: M0054665Z0
• Device Catalogue Number: 4665Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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
• Patient Sex: Female