Edge SDK4900-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521545571), received between Apr 7, 2017 and Oct 2, 2024 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER REMOVING THE WORKING CHANNEL FROM THE PATIENT, THE NURSE NOTICED WHAT APPEARED TO BE A VERY THIN 'WIRE' AT THE TIP OF THE CATHETER WHEN IT WAS FLUSHED. THE USER TRIED TO RETRIEVE IT, BUT IT COULD NOT BE GRABBED AND WAS SOMEHOW LOST OUTSIDE OF THE PATIENT'S BODY. THE VERY THIN WIRE APPEARED TO COME FROM INSIDE THE CATHETER. TO RESOLVE THE ISSUE, A NEW CATHETER WAS USED. IT WAS NOTED THAT NO FRAGMENTS WERE IN THE PATIENT¿S BODY. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351147 ↗
• InjurySep 20, 2021Application Program Problem; Connection Problem; Application Program Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE'S LG WAS DETECTED AS ALREADY USED. IT WAS THE LAST KIT SO THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ENB PORTION OF THE CASE.

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

  MAUDE report 12495098 ↗
• InjuryMar 9, 2021Patient Data Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DOCTOR DID NOT HAVE A GOOD 3D TREE AND DECIDED TO PLAN FOR MANUAL REGISTRATION. WHEN THE DOCTOR TRIED AUTOMATIC REGISTRATION TWICE AND MANUAL REGISTRATION TWICE, THEY ASKED IF THEY COULD GET A NEW "LOCATABLE GUIDE" TO SEE IF THIS WOULD HELP THEM WITH "REGISTERING" THE PATIENT'S AIRWAYS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE CASE WAS NOT COMPLETED BY OTHER MEANS.

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

  MAUDE report 11445409 ↗
• InjurySep 15, 2020Application Program Problem; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN COULD NOT PROCEED WITH PROCEDURE ACCORDING TO COMPUTER SCREEN.

  Patient problems: No Code Available

  MAUDE report 10536583 ↗
• InjuryMay 13, 2020Migration or Expulsion of Device; Application Program Problem; Migration or Expulsion of Device; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN HAD ISSUES DEPLOYING THE FIDUCIALS, EACH ONE MIGRATED UPON DEPLOYING OUT OF THE END OF THE MARKER DELIVERY KITS. WHEN TECH WAS LOADING THE FIDUCIAL INTO THE FIRST MARKER DELIVERY KIT IT BECAME LODGED IN THE PROXIMAL HUB AND COULD NOT ADVANCE THE GUIDE WIRE. THE SUPERD PORTION WAS NOT COMPLETED. IT WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10054040 ↗
• MalfunctionNov 18, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DEVICE WAS INDICATED AS OUTSIDE OF THE SENSOR SENSING VOLUME. 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 9337397 ↗
• MalfunctionNov 1, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, STRING LIKE FRAGMENTS OF THE WORKING CHANNEL WERE PULLED BACK WITH THE TISSUE SAMPLE WHEN MAKING PASSES WITH A COMPETITIVE FORCEPS TOOL. THE SUPERD PORTION OF THE CASE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268464 ↗
• InjuryAug 6, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER. DURING A PROCEDURE THE HEALTH CARE PROFESSIONAL CALLED TECHNICAL SERVICES INDICATING THERE WAS AN ERROR THAT THE LOCATABLE GUIDE WAS ALREADY USED. A NEW LOCATABLE GUIDE WAS THEN USED, THE SYSTEM WAS RESTARTED TWICE, AND THE SAME ERROR CODE CAME ON. THE PREVIOUS CASE WITH THE SYSTEM WAS COMPLETED WITH NO ISSUES, HOWEVER DURING THIS CASE, THE OLD CASE AUTOMATICALLY POPPED UP AS THE PROCEDURE WAS NOT EXITED PROPERLY, WITH A NEW LOCATABLE GUIDE HOOKED UP. THIS CAUSED THE LOCATABLE GUIDE TO BE READ AS THE PREVIOUS CASE, AND WHEN THE CORRECT PATIENT WAS CHOSEN, THE ERROR CAME UP. DURING TROUBLESHOOTING THE CORRECT PATIENT WAS CHOSEN AND A NEW GUIDE WAS REPLACED, AND THE SAME ERROR CAME UP AGAIN. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PHYSICIAN DID NOT COMPLETED THE CASE.

  Patient problems: No Code Available

  MAUDE report 8865790 ↗
• MalfunctionApr 24, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHILE USING A FORCEPS, A PLASTIC SUBSTANCE WAS NOTICED COMING OUT OF THE EXTENDED WORKING CHANNEL. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546120 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED WAS PNEUMOTHORAX. MULTIPLE TOOLS WERE USED FOR BIOPSY. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. THE PATIENT VISITED ER IN THE EVENING ON (B)(6) 2019 A PIGTAIL WAS PLACED.

  Patient problems: Pneumothorax

  MAUDE report 8279573 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ENB PROCEDURE, THE PATIENT EXPERIENCED PNEUMOTHORAX. THEY NOTED THAT THERE WAS NO PRODUCT ISSUE. NO TREATMENT WAS REQUIRED. THEY WERE ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE.

  Patient problems: Pneumothorax

  MAUDE report 7722255 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON PHYSICIAN'S 5 DAYS POST-OP FOLLOW UP CALL AFTER A SUPERDIMENSION ENB PROCEDURE, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH. A CHEST X-RAY WAS ORDERED AND THE PATIENT WAS FOUND TO HAVE A PNEUMOTHRAX. A CHEST TUBE WAS INSERTED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT ALSO DEVELOPED A LARGE PLEURAL EFFUSION.

  Patient problems: Pneumothorax

  MAUDE report 6629265 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT WHILE NAVIGATING TO THE RIGHT LOWER LOBE DURING A SUPERDIMENSION ENB PROCEDURE THE PATIENT BEGAN BLEEDING AND REQUIRED INTERVENTION FROM A RIGID BRONCHOSCOPE TO STOP BLEEDING. THE BLEEDING LASTED APPROXIMATELY TWO HOURS AND THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. THERE WAS NO PRODUCT DEFICIENCY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6567393 ↗
• InjuryApr 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS FOUND A PATIENT HAD A PNEUMOTHORAX AFTER A SUPERDIMENSION ENB PROCEDURE. THE PHYSICIAN REPORTED THE EDGE SENSOR CATHETER WAS NOT REGISTERING AND WAS ACTING ERRATIC. THE PHYSICIAN COMPLETED BRUSHING THE NODULE SITE VIA FLUORO GUIDANCE IN LIEU OF NAVIGATION. NO PNEUMOTHORAX WAS NOTED AT TIME OF PROCEDURE VIA FLUORO. PATIENT HAD A CHEST TUBE PLACED AND WAS HOSPITALIZED. THE PATIENT WAS RELEASED ON (B)(6) 2017.

  Patient problems: Pneumothorax

  MAUDE report 6471218 ↗