superDimension SDBF1000 (UDI 10884521809543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521809543), received between Jul 1, 2022 and Jul 19, 2022 — classified as 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE BIOPSY ON THE RIGHT LUNG (GROUND GLASS OPACITIES), NEEDLE AND FORCEPS WERE USED AND NO BLEEDING WAS FOUND. WHEN THE PROCEDURE ENDED AND THE SURGEON WAS DOING MINI BRONCHOALVEOLAR LAVAGE SAMPLING FOR THE SECOND TIME, BLEEDING WAS FOUND ON THE SECOND TIME. 600 MILLIMETERS OF BLOOD LOSS WAS REPORTED. THE PATIENT IS ALIVE WITH TWO DAYS STAY IN HOSPITAL. ONE DAY FOR OBSERVATION AND ANOTHER DAY FOR CHEST X-RAY BEFORE DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 15054586 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING THE PROCEDURE, THE DEVICES HAD NO DEFECTS AND THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE. THE PATIENT EXPERIENCED PNEUMOTHORAX AND HAD TO USED CHEST TUBE. THE EVENT HAS LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: Pneumothorax

  MAUDE report 14887590 ↗