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

Model Number M00546650

Device Problem Connection Problem (2900)

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

Event Date 02/02/2024

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

It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed for the treatment of bile duct stones on february 2, 2024.During the preparation, the spy ds controller will turn on and powers up normally, however, the image on the screen was lost because of the loose connection between the spyscope and the controller.They stated that the locking tab of the spyscope ds catheter cable connector was facing up when it was plugged into the controller receptacle, and it did engage when the cable connector was pushed in.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed for the treatment of bile duct stones on (b)(6) 2024.During the preparation, the spy ds controller will turn on and powers up normally, however, the image on the screen was lost because of the loose connection between the spyscope and the controller.They stated that the locking tab of the spyscope ds catheter cable connector was facing up when it was plugged into the controller receptacle, and it did engage when the cable connector was pushed in.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.Note: the customer reported that the event occurred pre-procedure with no patient involvement and was not sedated.

Manufacturer Narrative

Block h2 (additional information): block b5 and block h6 (imdrf impact code) have been updated based on the additional information received on march 27, 2024.Block h10: additional information received on march 27, 2024, confirmed that this is no longer considered a reportable event.The customer reported that the event occurred pre-procedure with no patient involvement and was not sedated.

• 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: 18788707
• MDR Text Key: 336338808
• Report Number: 3005099803-2024-00654
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1