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

Model Number M00546650

Device Problem Poor Quality Image (1408)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a spyglass digital controller was used in the bile duct during a cholangioscopy procedure performed on june 1, 2023.During the procedure, no image appeared on the screen when the spyscope ds ii plugged into the spyglass ds controller.They tried to use three different spyscope ds ii catheters, however, it did not work.The three spyscope ds ii were tested and work as intended with a different spyglass ds controller since the event.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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 top cover has finish damage and front panel is cracked.Bumper is also damaged.Catheter interface contacts have contamination which is causing an interrupted video connection.The contacts require replacement to repair this controller.The problem 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.

Event Description

It was reported to boston scientific corporation that a spyglass digital controller was used in the bile duct during a cholangioscopy procedure performed on (b)(6) 2023.During the procedure, no image appeared on the screen when the spyscope ds ii plugged into the spyglass ds controller.They tried to use three different spyscope ds ii catheters, however, it did not work.The three spyscope ds ii were tested and work as intended with a different spyglass ds controller since the event.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
• 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: 17176045
• MDR Text Key: 317812829
• Report Number: 3005099803-2023-03367
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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
• 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?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1