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

Model Number M00546650

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the serial number; therefore, the manufacture date and expiration date are unknown.Imdrf impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.

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 the bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost approximately twenty minutes into the procedure.An electrohydraulic lithotripsy (ehl) was used in combination with the spyscope ds ii to perform lithotripsy; however, the image was lost.The procedure was not completed due to this event and was rescheduled on (b)(6) 2023.There were no patient complications reported as a result of this event.

Manufacturer Narrative

It was reported that the controller has been tested since this event and worked as intended.The aborted procedure is captured under mdr# 3005099803-2023-01143.

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 the bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost approximately twenty minutes into the procedure.An electrohydraulic lithotripsy (ehl) was used in combination with the spyscope ds ii to perform lithotripsy; however, the image was lost.The procedure was not completed due to this event and was rescheduled on (b)(6) 2023.There were no patient complications reported as a result of this event.Additional information was received on march 09, 2023: it was reported that the controller has been tested since this event and worked as intended.

• 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: 16485575
• MDR Text Key: 310695001
• Report Number: 3005099803-2023-01143
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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: 03/09/2023
• 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