superDimension SDNB2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521200531), received between Mar 21, 2017 and Feb 3, 2021 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PHYSICIAN USED THE TOWER WITH A KIT, NAVIGATED TO THE TARGET AND USED RADIAL EBUS FOR CONFIRMATION THEN USED THE FOLLOWING ENDOSCOPIC TOOLS: BRUSH, FORCEPS AND SUPERTRAX NEEDLE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE, HOWEVER, THE PATIENT EXPERIENCED BLEEDING. EPINEPHRINE, SALINE AND TAMPONADE WERE USED TO RESOLVE THE BLEEDING. THE PHYSICIAN WAS ABLE TO TAMPONADE THE BIOPSY SITE WITH SCOPE TO CONTROL AND GET THE BLEEDING TO STOP. OUT OF AN ABUNDANCE OF CAUTION THE PATIENT WAS LEFT INTUBATED AND ADMITTED FOR OVERNIGHT OBSERVATION IN THE SURGICAL INTENSIVE CARE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11271908 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER A PNEUMOTHORAX WAS DISCOVERED AFTER THE CASE. THEY WERE NOT SURE WHICH DEVICE CAUSED THE EVENT. THE PATIENT IS STILL ADMITTED IN THE HOSPITAL.

  Patient problems: Pneumothorax

  MAUDE report 8499913 ↗
• DeathMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENB PROCEDURE FOR BIOPSY OF A SUSPICIOUS LESION AND FIDUCIAL MARKER PLACEMENT. THE PATIENT HAD A BLOOD LOSS OF APPROXIMATELY 350CC FOLLOWING BIOPSY WITH UNKNOWN NEEDLE TIPPED CYTOLOGY BRUSH AND PROCEDURE WAS ABORTED. IT IS UNKNOWN WHAT TYPE OF TREATMENT WAS GIVEN TO STOP BLEEDING. THE PATIENT WAS EXTUBATED AND TAKEN TO THE RECOVERY ROOM WHERE SHE SUBSEQUENTLY ARRESTED AND DIED. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES ARE AVAILABLE.

  Patient problems: Blood Loss; Death

  MAUDE report 6420896 ↗