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

Model Number M00546650

Device Problems Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Note: this report pertains to a spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in during biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii flickered and became disturbed in the middle of the procedure during electrohydraulic lithotripsy (ehl), and after a while the image on the screen disappeared.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

He complainant was unable to report the upn and serial number; therefore, the unique identifier (udi) #, manufacture date, and expiration date are unknown.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Manufacturer Narrative

This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.Block h10: it was reported that the controller has been used and work as intended since this event.The aborted procedure is captured under mdr# 3005099803-2023-01205.Block h11: correction - block d7a (sud reprocessed and reused?) has been corrected.

Event Description

Note: this report pertains to a spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in during biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii flickered and became disturbed in the middle of the procedure during electrohydraulic lithotripsy (ehl), and after a while the image on the screen disappeared.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on march 12, 2023: it was reported that the spyglass ds controller is not available for return because the controller is still in service which indicates that the spyglass ds controller has been used and work as intended since 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: 16501596
• MDR Text Key: 311308059
• Report Number: 3005099803-2023-01206
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/12/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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