Edge SDK4190-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521581388), received between Apr 13, 2017 and Mar 13, 2024 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 13, 2024Application Program Problem; Adverse Event Without Identified Device or Use Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AFTER REGISTRATION WHILE ATTEMPTING TO NAVIGATE OUT TO THE LESION, THE PHYSICIAN EXPERIENCED MODERATE BLEEDING. THE BLEEDING WAS OBSERVED FOLLOWED THE INTRODUCTION OF THE CATHETER INTO THE PERIPHERAL AIRWAY. THE PHYSICIAN REMOVED THE CATHETER AND FLUSHED WITH SALINE AND EPINEPHRINE TO CONTROL THE BLEEDING. AFTER BLEEDING WAS CONTROLLED, THE CATHETER WAS PUT BACK IN. SHORTLY AFTER, THE ANESTHESIOLOGIST NOTED A SUDDEN DROP IN BLOOD PRESSURE OF THE PATIENT RESULTING IN A CODE AND CHEST COMPRESSIONS TWICE TO STABILIZE. THE PHYSICIAN PULLED THE CATHETER AND SCOPE. PATIENT DID NOT RESPOND TO ANESTHESIA INTERVENTIONS. THE PATIENT WAS STABILIZED AND BROUGHT TO THE INTENSIVE CARE UNIT (ICU). THE SUPERDIMENSION PORTION OF THE CASE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT HAD HEART FAILURE WITH THE INDUCTION OF SEDATION. THE PATIENT HAS DECEASED. THE PATIENT'S DEATH HAS NO RELATIONSHIP WITH THE DEVICE ISSUE AND STEMMED FROM ANESTHESIA EVENT MOST LIKELY FROM HEART FAILURE FROM SEDATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18892090 ↗
• InjuryMar 17, 2022Retraction Problem; Application Program Problem; Activation, Positioning or Separation Problem; Retraction Problem; Application Program Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN WAS HAVING DIFFICULTY PUSHING AND RETRACTING THE EXTENDED WORKING CHANNEL (EWC). EVENTUALLY THE CATHETER AND LOCATABLE GUIDE (LG) WERE REMOVED FROM THE PATIENT/SCOPE BUT REALIZED THE TIP OF THE LG HAD COME OFF OF THE PRODUCT. IT WAS LATER FOUND IN THE WORKING CHANNEL OF THE SCOPE. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13791452 ↗
• MalfunctionSep 4, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE, A STRING-LIKE FIBER CAME OUT OF THE CATHETER ON THE BACK TABLE WHEN INSERTING TOOLS THROUGH THE CATHETER AFTER A NEEDLE WAS USED. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960227 ↗
• MalfunctionMay 29, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN THE PROFESSOR WAS TRYING TO USE THE BIOPSY FORCEPS TO TAKE LUNG TISSUE FROM THE PATIENT, PLASTIC WAS TAKEN OUT AS WELL. WHEN THEY TRIED TO TAKE A SECOND TIME, PLASTIC WAS TAKEN OUT WITH LUNG TISSUE AGAIN. THEY CHANGED TO A NEW EWC AND NO PLASTIC WAS FOUND AFTERWARDS. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8652595 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE PATIENT HAD A PNEUMOTHORAX. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE PNEUMOTHORAX. DURING THE PROCEDURE, THEY ONLY PERFORMED SIGHT SPECIFIC BAL FOR SAMPLING. THE PHYSICIAN COMPLETED THE CASE AND PNEUMOTHORAX WAS DISCOVERED AFTER THE PROCEDURE. THE PATIENT WAS ADMITTED AND CHEST TUBE WAS PLACED.

  Patient problems: Pneumothorax

  MAUDE report 7503108 ↗
• MalfunctionApr 13, 2017Material Deformation; Material Deformation

  SITE REPORTED A STRING-LIKE FIBER FROM THE EXTENDED WORKING CHANNEL CATHETER WAS ON THE FORCEPS (NON-SUPERDIMENSION FORCEPS) WHILE TAKING BIOPSY ON TISSUE DURING A SUPERDIMENSION ENB PROCEDURE. THE SITE REPORTED NOTHING WAS LEFT BEHIND IN THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY, DEATH, OR OTHER SERIOUS ADVERSE EVENT AND NOTHING WAS LEFT BEHIND IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490107 ↗