ILLUMISITE ILS-1000-CS (UDI 10884521812383)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521812383), received between Sep 23, 2022 and Jun 17, 2024 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Application Program Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K191394); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2024Application Network Problem; Application Program Problem; Application Network Problem; Application Program Problem

  ACCORDING TO THE REPORTER, THERE WAS A SYSTEM ACCURACY ISSUE. THE CASE HAD TO BE CANCELLED AS A RESULT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19548290 ↗
• InjuryJun 17, 2024Application Network Problem; Application Program Problem; Application Network Problem; Application Program Problem

  ACCORDING TO THE REPORTER, THERE WAS A SYSTEM ACCURACY ISSUE. THE CASE HAD TO BE CANCELLED AS A RESULT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19548222 ↗
• DeathOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED BLEEDING COMPLICATIONS DURING THE ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PORTION OF THE PROCEDURE AFTER ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) HAD CONCLUDED. THE PATIENT REQUIRED INTUBATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS EVENTUALLY EXTUBATED BUT HAD FURTHER COMPLICATIONS AND EVENTUALLY EXPIRED ON THE 5TH DAY AFTER THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17861122 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Patient Data Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE REGISTRATION WAS NOT WORKING. ALL THE DATA POINTS WERE SHIFTED TO THE RIGHT. THE SURGEON WAS IN THE RIGHT UPPER LUNG AND THE DATA POINTS WERE REGISTERING ON THE LEFT UPPER LUNG. ADDITIONALLY, THE PATIENT HAD PNEUMOTHORAX. TO RESOLVE THE ISSUE, A CHEST TUBE WAS USED. THE PATIENT HOSPITALIZATION WAS EXTENDED.

  Patient problems: Pneumothorax

  MAUDE report 17765045 ↗
• InjuryAug 23, 2023Application Network Problem; Application Program Problem; Patient Data Problem; Application Network Problem; Application Program Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, DURING A FNAV BRONCHOSCOPY WITH BIOPSY, THE DOCTOR COULD NOT COMPLETE AUTOMATIC OR MANUAL REGISTRATION. THERE WAS ALSO A SYSTEM INACCURACY, AS THE RIGHT LUNG REGISTRATION DATA APPEARED ON TOP ON LEFT LUNG REGISTRATION DATA.  BIOPSIES WAS NOT ABLE TO BE TAKEN. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE, EVEN BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS NOTED THAT THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605347 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Patient Data Problem; Adverse Event Without Identified Device or Use Problem; Patient Data Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX WITHIN A COUPLE OF HOURS AFTER THE BIOPSY. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE DEVICE. TO RESOLVE THE ISSUE, A CHEST TUBE WAS USED.

  Patient problems: Pneumothorax

  MAUDE report 17599106 ↗
• InjuryMar 28, 2023Application Program Problem; Adverse Event Without Identified Device or Use Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT WITH GENERAL ANESTHESIA HAD BLEEDING DURING NAVIGATION AND HAD AIRWAY INJURY. EPINEPHRINE INJECTION WAS USED TO STOP THE BLEEDING. PROCEDURE WAS ABORTED BEFORE BIOPSIES WERE ATTEMPTED. HENCE, THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE WAS NOT COMPLETED EVEN BY OTHER MEANS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16629189 ↗
• InjurySep 23, 2022Application Program Problem; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, A 90 CATHETER KINKED AND DAMAGED. THE PROCEDURE WAS NOT COMPLETED AND IT WAS UNKNOWN IF IT WAS COMPLETED BY OTHER MEANS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15474094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191394. One submission often covers many models, so check the product and lot details in each record.

• Z-2008-2023 · May 22, 2023 · Open, Classified
  Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS