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

Model Number M00546650

Device Problems Poor Quality Image (1408); Optical Problem (3001)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06372 for the first spyscope ds ii, report number 3005099803-2023-06373 for the second spyscope ds ii and report number for the spy ds controller.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and per-oral cholangioscopy (poc) procedures performed for the diagnosis of stricture in the bile duct on (b)(6) 2023.During the procedure, the first spyscope ds ii malfunctioned after a couple of minutes of usage and then five grey dots appeared across the screen.A second spyscope ds ii was then used; however, no image appeared and went back to the initial start-up screen asking them to connect the device.The spyscope ds ii was unplugged and re-plugged from the spy ds controller, but the image was not displayed.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: 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, the evaluation noted that the luminance/ chrominance (y/c) video output connectors and video graphics adapter (vga) output connector is damaged.Top cover has finish damage and connector socket is discolored.There is unknown contamination on the catheter contacts causing a poor connection between the catheter and the interface pc board.There is also damage to the light engine or light emitting diode (led) which is not repairable due to obsolete parts.The light engine requires an upgrade for repair.The problem was verified according to product analysis.Per the evaluation conducted by enercon technologies, the reported complaint was confirmed.The problem is unlikely related to manufacturing.The product analysis identified problems related to use and maintenance and did not identify any manufacturing defect.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.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-06372 for the first spyscope ds ii, report number 3005099803-2023-06373 for the second spyscope ds ii and report number 3005099803-2023-06371 for the spy ds controller.It was reported to boston scientific corporation that the two spyscope ds ii access & delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) and per-oral cholangioscopy (poc) procedures performed for the diagnosis of stricture in the bile duct on (b)(6), 2023.During the procedure, the first spyscope ds ii malfunctioned after a couple of minutes of usage and then five grey dots appeared across the screen.A second spyscope ds ii was then used; however, no image appeared and went back to the initial start-up screen asking them to connect the device.The spyscope ds ii was unplugged and re-plugged from the spy ds controller, but the image was not displayed.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: SPYGLASS DS
• 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 ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18301593
• MDR Text Key: 330173314
• Report Number: 3005099803-2023-06371
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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