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

Model Number M00542950

Device Problems Poor Quality Image (1408); Optical Problem (3001)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the serial number; therefore, the manufacture date is unknown.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to spyglass discover digital catheter and spyglass discover digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that spyglass discover digital catheter was used during percutaneous cholangioscopy procedure performed on (b)(6) 2023.During the procedure, the image on the screen began to flicker on and off, then the image cut out and went black.The screen then showed five flashing 'loading' dots, and then went black again.Attempts were made to unplug and re-plug the device back into the controller and these attempts were unsuccessful at regaining the image on the screen, the device lost visualization.The procedure was not completed due to this event.No patient complications have been 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: 16719618
• MDR Text Key: 313139510
• Report Number: 3005099803-2023-01815
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• 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: 04/11/2023

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: M00542950
• Device Catalogue Number: 1614-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/11/2023
• 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