superDimension SDAN1000 (UDI 10884521200494)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521200494), received between Jun 28, 2017 and Feb 3, 2021 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 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 TO RESOLVE THE BLEEDING. THE PHYSICIAN WAS ABLE TO TAMPONADE THE BIOPSY SITE WITH SCOPE TO CONTROL AND GET 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 11272479 ↗
• 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 8499977 ↗
• 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 8279587 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A BIOPSY DURING AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY PROCEDURE AND POST-OPERATIVELY, THE PATIENT HAD A PNEUMOTHORAX. THE PHYSICIAN COMPLETED THE CASE SUCCESSFULLY AND IT WAS NOT DISCOVERED UNTIL THE PATIENT WAS IN POST-OP. A REPEAT CT SCAN WAS DONE AND THE PNEUMOTHORAX WAS RESOLVED. THE PATIENT WAS DISCHARGED SAME DAY.

  Patient problems: Pneumothorax

  MAUDE report 7333531 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT GOT A PNEUMOTHORAX DURING A SUPERDIMENSION ENB PROCEDURE BIOPSY. A PIGTAIL WAS PLACED AND THE PATIENT WAS HOSPITALIZED OVERNIGHT. THERE WERE NO REPORTED ISSUES WITH THE DEVICE.

  Patient problems: Pneumothorax

  MAUDE report 6675744 ↗