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

Model Number M00546650

Device Problem Optical Problem (3001)

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

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the serial number; therefore, the manufacture date and expiration date are unknown.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 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 spyscope ds ii access & delivery catheter was used during an electrohydraulic lithotripsy (ehl) procedure performed (b)(6)2023.During the procedure, the image on the screen disappeared while crushing the stone and treatment could not be continued, therefore procedure was rescheduled.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: 16955978
• MDR Text Key: 315499954
• Report Number: 3005099803-2023-02629
• Device Sequence Number: 1
• Product Code: NTN
• 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
• Report Date: 05/18/2023

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: 04/24/2023
• Initial Date FDA Received: 05/18/2023
• 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