SPYGLASS DISCOVER DIGITAL CONTROLLER
Received Nov 21, 2023 · Event occurred Oct 26, 2023
Report 3005099803-2023-06253 · MDR key 18185969
Device
Generic name
Led Light Source
Manufacturer
Enercon TechnologiesModel number
M0054295R0Catalog number
1614-03
Lot number
2103507367
Product problems
- Connection Problem
- Connection Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.
Description of Event or Problem
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.