superDimension AKI00100-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521200463), received between Oct 25, 2016 and Jul 9, 2024 — 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.

• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED... BLEEDING IN ONE PATIENT. THE PATIENT WITH BLEEDING DEVELOPED POSTOPERATIVE HYPOXEMIA AND REQUIRED OVER-NIGHT HOSPITALIZATION. THE PATIENT ALSO REQUIRED TOPICAL TRAXEMENIC ACID AND TOPICAL EPINEPHRINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19704645 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX IN THREE PATIENTS. A CHEST TUBE WAS REQUIRED TO TREAT PNEUMOTHORAX IN TWO PATIENTS.

  Patient problems: Pneumothorax

  MAUDE report 19703611 ↗
• InjuryJun 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IN RECOVERY AFTER A SUPERDIMENSION ENB PROCEDURE WHEN A PNEUMOTHORAX WAS IDENTIFIED. UNABLE TO DETERMINE WHAT CAUSED THE PNEUMOTHORAX. A CHEST TUBE WAS PLACED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2017.

  Patient problems: Pneumothorax

  MAUDE report 6671227 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PNEUMOTHORAX WAS DISCOVERED AFTER A SUPERDIMENSION ENB PROCEDURE. A CHEST TUBE WAS REQUIRED AND THE PATIENT WAS HOSPITALIZED. PHYSICIAN WAS UNABLE TO DETERMINE WHAT CAUSED THE PNEUMOTHORAX. PATIENT ALSO REPORTED TO HAVE LEFT LOWER LOBE PNEUMONIA AND RIGHT PLEURA INFUSION AND NOW MOVING FORWARD TO VATS.

  Patient problems: Pneumothorax

  MAUDE report 6629246 ↗
• InjuryOct 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATENT WAS DESATURATED TO 83%, WITH SURGICAL EMPHYSEMA AND RESPIRATORY DISTRESS. NO CHEST SOUNDS ON THE LEFT SIDE.

  Patient problems: Pneumothorax

  MAUDE report 6053498 ↗