MalfunctionNTN
SPYGLASS DISCOVER DIGITAL CONTROLLER
Received May 27, 2026 · Event occurred Apr 29, 2026
Report 3005099803-2026-02141 · MDR key 25301391
Device
Generic name
Led Light Source
Manufacturer
Enercon TechnologiesModel number
M00542950Catalog number
M00542950
Lot number
2205601169
Product problems
- Failure to Power Up
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CONTROLLER WAS INTENDED FOR USE IN AN ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. IN PREPARATION PRIOR TO THE PROCEDURE, THE SPY DISCOVERER CONTROLLER DID NOT POWER ON. THE PROCEDURE WAS CANCELLED AND RESCHEDULED AS RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.