inforMED
MalfunctionNTN

SPYGLASS DISCOVER DIGITAL CONTROLLER

Received Jun 8, 2022 · Event occurred May 14, 2022

Report 3005099803-2022-03203 · MDR key 14629548

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Product code (NTN)
Manufacturer (Enercon Technologies)

Device

Generic name

Led Light Source

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Optical Problem
  • Adverse Event Without Identified Device or Use Problem
  • 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 REPORT THE UPN AND SERIAL NUMBER; THEREFORE THE UNIQUE IDENTIFIER (UDI) #, MANUFACTURE DATE, AND EXPIRATION DATE ARE UNKNOWN. (INITIAL REPORTER ADDRESS 1): (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, VISUALIZATION WAS LOST. EACH TIME THEY PLUGGED THE DEVICE IN, VISUALIZATION WOULD POP UP FOR A MOMENT THEN THE IMAGE WAS LOST. THEY TRIED TO PLUGGED THE DEVICE IN AND OUT, SWITCHED MONITORS, BUT NOTHING WORKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND SERIAL NUMBER; THEREFORE THE UNIQUE IDENTIFIER (UDI) #, MANUFACTURE DATE, AND EXPIRATION DATE ARE UNKNOWN. BLOCK E1 (INITIAL REPORTER ADDRESS 1): (B)(6). BLOCK H10: IT WAS REPORTED THAT THE CONTROLLER HAS BEEN TESTED SINCE THIS EVENT AND WORKED AS INTENDED. THE ABORTED PROCEDURE IS CAPTURED UNDER MDR# 3005099803-2022-03101.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, VISUALIZATION WAS LOST. EACH TIME THEY PLUGGED THE DEVICE IN, VISUALIZATION WOULD POP UP FOR A MOMENT THEN THE IMAGE WAS LOST. THEY TRIED TO PLUGGED THE DEVICE IN AND OUT, SWITCHED MONITORS, BUT NOTHING WORKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 08, 2022: IT WAS REPORTED THAT THE CONTROLLER HAS BEEN TESTED SINCE THIS EVENT AND WORKED AS INTENDED.