inforMED
MalfunctionNTN

SPYGLASS DISCOVER DIGITAL CONTROLLER

Received Apr 11, 2023 · Event occurred Mar 17, 2023

Report 3005099803-2023-01815 · MDR key 16719618

Device

Generic name

Led Light Source

Model number

M00542950

Catalog number

1614-03

Product problems

  • Poor Quality Image
  • Optical Problem
  • Poor Quality Image
  • Optical Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional 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.

Description of Event or Problem

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.