MAUDE Adverse Event Report: ENERCON TECHNOLOGIES SPYGLASS DISCOVER DIGITAL CONTROLLER; LED LIGHT SOURCE

Model Number M0054295R0

Device Problem Connection Problem (2900)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): 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 spyglass discover digital controller were used in the procedure on october 26, 2023.During the procedure, the digital visual interface (dvi) connection on the back of the controller was found to be faulty.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS DISCOVER DIGITAL CONTROLLER
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): ENERCON TECHNOLOGIES; 25 northbrook drive; gray ME 04039
• 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: 18185969
• MDR Text Key: 328944125
• Report Number: 3005099803-2023-06253
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729998754
• UDI-Public: 08714729998754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054295R0
• Device Catalogue Number: 1614-03
• Device Lot Number: 2103507367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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