superDimension AKI00133-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521200487), received between Sep 22, 2016 and Apr 29, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN DECEMBER 2019 AND FEBRUARY 2020, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY UTILIZING SUPERDIMENSION 7.2 FOR THE EVALUATION OF PERIPHERAL PULMONARY NODULES BETWEEN DECEMBER 2019 AND FEBRUARY 2020. EACH PATIENT HAD 7 FINE NEEDLE ASPIRATIONS WITH THE ARCPOINT 18-GAUGE NEEDLE AND 7 FORCEPS SAMPLES COLLECTED WITH THE SUPERDIMENSION BIOPSY FORCEPS. THERE WERE 72 PATIENTS IN THE STUDY, 56 RECEIVED MODERATE SEDATION AND 16 RECEIVED GENERAL ANESTHESIA. FOR SAMPLES DEEMED TO HAVE A NONSPECIFIC DIAGNOSIS, OR PATHOLOGIC FINDING OF ACUTE INFLAMMATION WAS IDENTIFIED AND REPEAT CT SCAN OF THE CHEST DEMONSTRATED A RESOLVED ABNORMALITY, OR HAD FLUOROSCOPY NAVIGATION FAILURE, THESE BIOPSIES WERE CALCULATED AS NONDIAGNOSTIC. COMPLICATIONS IN THE MODERATE SEDATION GROUP INCLUDED 2 PNEUMOTHORAX, WHICH DID NOT REQUIRE CHEST TUBE INSERTION. NO COMPLICATIONS OCCURRED IN THE GENERAL ANESTHESIA GROUP. THERE WAS ONE FLUOROSCOPY NAVIGATION FAILURE IN THE MODERATE SEDATION GROUP (SAMPLES TAKEN BUT NO DIAGNOSIS OBTAINED). THIS COULD PARTIALLY BE BECAUSE OF THE INABILITY TO PERFORM A BR

  Patient problems: Pneumothorax

  MAUDE report 14250511 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT RECEIVED A RIGHT SIDED PNEUMOTHORAX. PROCEDURE WAS PERFORMED WITH NO APPARENT ISSUE. IT IS UNKNOWN WHAT SPECIFICALLY CAUSED THE PNEUMOTHORAX. A CHEST TUBE WAS INSERTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION.

  Patient problems: Pneumothorax

  MAUDE report 9234582 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A PNEUMOTHORAX WHICH WAS IDENTIFIED AFTER BIOPSY DURING A SUPERDIMENSION ENB PROCEDURE. A CHEST TUBE WAS INSERTED AND THE PATIENT WAS HOSPITALIZED TWO DAYS.

  Patient problems: Pneumothorax

  MAUDE report 6829636 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A SMALL PNEUMOTHORAX WHICH SHOWED UP ON X-RAY AFTER A SUPERDIMENSION ENB BIOPSY PROCEDURE. THE DOCTOR ADMITTED THE PATIENT OVERNIGHT FOR OBSERVATION.

  Patient problems: Pneumothorax

  MAUDE report 6587889 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A PNEUMOTHORAX FROM BIOPSY DURING A SUPERDIMENSION ENB PROCEDURE. PATIENT REQUIRED CHEST TUBE PLACEMENT.

  Patient problems: Pneumothorax

  MAUDE report 6587852 ↗
• InjurySep 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD ENDOBRONCHIAL BLEEDING (100ML) AFTER SAMPLING DURING AN SUPERDIMENSION ENB PROCEDURE. LOCAL TAMPONADE WAS APPLIED AND THROMBIN AND EPI WAS ADMINISTERED.

  Patient problems: Blood Loss

  MAUDE report 5969640 ↗