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

Model Number	M0054665R0
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Notes: this report pertains to two spyscope ds ii complaints and spy ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints and spy ds controller were used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2023.During preparation, the customer tried to insert two spyscope ds ii of different batch number, but the controller did not recognize any of the spyscope ds ii.They tried to turn the controller on and off for several times and also disconnecting and reconnecting the power supply, however; the problem was not resolved.The procedure was not completed due to this event and reschedule on (b)(6) 2023.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/cancelled procedure.
Event or Problem Description
Notes: this report pertains to two spyscope ds ii complaints and spy ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints and spy ds controller were used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2023.During preparation, the customer tried to insert two spyscope ds ii of different batch number but the controller did not recognize any of the spyscope ds ii.They tried to turn the controller on and off for several times and also disconnecting and reconnecting the power supply, however; the problem was not resolved.The procedure was not completed due to this event and reschedule on (b)(6) 2023.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/cancelled procedure.Block h10: investigation results the returned spyglass digital controller was analyzed by enercon technologies, and the evaluation noted that the front panel has finish defects.Confirmed the video would cut in and out as the scope was moved.The catheter interface contacts have unknown contamination and are causing the intermittent video.The contacts require replacement to repair this unit.The issue was verified according to product analysis.Per the evaluation conducted by enercon technologies, the reported complaint was confirmed.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.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 labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 17362682
• Report Number: 3005099803-2023-03827
• Device Sequence Number: 17652683
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2016
• 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