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

Model Number	M00546650
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a spy ds controller was prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones in the bile duct on (b)(6) 2024.During set up for the procedure, the light source and system failed to turn on.Reportedly, the movement of the male connector of the scopes umbilicus temporarily restores functionality, indicating a likely loose connection in the controllers female connector.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block h11 (investigation results): with all the available information, boston scientific concludes that the reported event was confirmed.Although the number of procedures/recycles of the unit are unknown, contamination is likely due to repeat use and wear and tear on the catheter connection, or improper cleaning of the unit during maintenance.The returned spy ds controller was analyzed.It was found that the contamination on the catheter contacts is preventing a stable connection from the catheter.The allegation has been confirmed.Based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.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, there was an indication that the device was not used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a spy ds controller was prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones in the bile duct on (b)(6) 2024.During set up for the procedure, the light source and system failed to turn on.Reportedly, the movement of the male connector of the scopes umbilicus temporarily restores functionality, indicating a likely loose connection in the controller's female connector.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
• Common Device Name: 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 ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20358539
• Report Number: 3005099803-2024-04944
• Device Sequence Number: 8086376
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Device Lot Number: 1705800354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/21/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown