SPYGLASS DS

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS DIGITAL CONTROLLER WAS INTENDED FOR USE WITH A SPYSCOPE DS II DEVICE IN AN ENDOSCOPIC PROCEDURE ON (b)(6) 2026.DURING THE PROCEDURE, THE CONTROLLER BEGAN REBOOTING UNEXPECTEDLY AND SUBSEQUENTLY FAILED COMPLETELY, RESULTING IN LOSS OF THE VISUALIZATION. AFTER SWITCHING TO A SECOND SPYSCOPE DS II, THE SAME BEHAVIOR RECURRED. AS A RESULT, THE SYSTEM WAS NO LONGER AVAILABLE FOR THE PROCEDURE, AND THE DEVICE COULD NOT BE USED TO CONTINUE THE PROCEDURE AS INTENDED.NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6 (IMPACT CODES):IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.BLOCK D2B: SUBSEQUENT PRO CODES KQM, NTN.