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

Model Number	M0054665R0
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: this report pertains to two spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that spyscope ds ii access & delivery catheter and spyglass ds - digital controller, were used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with lithotripsy procedure performed on (b)(6) 2023.During the procedure, the spy image started getting choppy approximately two minutes into the procedure.Then five grey dots appeared on the screen.They reset spy and swapped out the s-video cable; however, nothing was changed.They opened a second spyscope ds ii and the same thing happened.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: 16448726
• Report Number: 3005099803-2023-00936
• Device Sequence Number: 5599763
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: M0054665R0
• Device Catalogue Number: 4665R
• Device Lot Number: 1730700980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown