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

Model Number	M00546650
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-02344 for the spyscope ds ii access & delivery catheter and 3005099803-2024-02308 for the spy ds controller.It was reported to boston scientific corporation that a spyscope dsii and spy ds controller were used during a cholangioscopy with lithotripsy procedure in the common bile duct for the treatment choledocholithiasis on (b)(6) 2024.It was reported that visualization was lost five minutes into the procedure.The physician decided to discontinue the procedure.It was rescheduled and completed on (b)(6) 2024.There were no reported patient complications 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 aborted/rescheduled procedure.

• 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: 19340082
• Report Number: 3005099803-2024-02308
• Device Sequence Number: 12597521
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 1832000003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2018
• 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