Arcpoint ILS-1800-PN (UDI 10884521723627)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521723627), received between Aug 14, 2018 and May 13, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. THE PATIENT HAD TO GET A CHEST TUBE. THE EVENT HAD LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PATIENT HAD TEMPORARY INJURY AS A RESULT.

  Patient problems: Pneumothorax

  MAUDE report 19299907 ↗
• 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 MILLILITERS 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 15055066 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD PNEUMOTHORAX. TO RESOLVE THE ISSUE, THE SURGEON USED A CHEST TUBE. THE PATIENT HAD TO EXTEND HOSPITALIZATION FOR ONE DAY.

  Patient problems: Pneumothorax

  MAUDE report 15027226 ↗
• InjuryMay 12, 2022Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, MONARCH ROBOTIC BRONCHOSCOPE WAS INTRODUCED INTO THE AIRWAYS TO IDENTIFY AND BIOPSY THE LOWER LEFT LUNG (LUL) NODULE WITH THE AID OF THE SYSTEM AND RADIAL PROBE ULTRASOUND. DURING NAVIGATION, THE TIP OF THE NEEDLE SEVERED/ BROKE OFF AND REMAINED IN THE PATIENT'S AIRWAYS. USING NAVIGATION, THE NEEDLE TIP WAS LOCALIZED AND THEN RETRIEVED USING FORCEPS FORCEPS WITHOUT COMPLICATION. POST PROCEDURE, CHEST X-RAY SHOWED NO FOREIGN BODY RETAINED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14376274 ↗
• 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 14250554 ↗
• MalfunctionOct 11, 2021Break; Retraction Problem; Break; Retraction Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE AT THE LAST PASS, THE NEEDLE OF THE DEVICE BROKE WHEN THEY ARE TAKING IT OUT. IT APPEARS THE INNER CHANNEL OF THE NEEDLE CAME OUT OF THE OUTER CHANNEL OF THE NEEDLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610379 ↗
• MalfunctionSep 9, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PULMONARY NEEDLE WAS LOOSE IN THE PATIENT WHEN IT WAS BEING USED TO COLLECT SAMPLE. THE NEEDLE WAS LOOSE IN THE PATIENT AND HAD TO BE RETRIEVED. THE CASE WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450951 ↗
• InjuryJan 15, 2019Break; Break

  A MEDWATCH FORM WAS RECEIVED STATING A PATIENT UNDERWENT AN ELECTIVE BRONCHOSCOPY. "AFTERWORD'S" THE AIRWAYS WERE REVISUALIZED AND THERE WAS NO EVIDENCE OF ACTIVE BLEEDING OR BRONCHOSCOPIC TRAUMA. THE ROBOTIC ENDOSCOPE WAS THEN RETRACTED BACK THROUGH THE ENDOTRACHEAL TUBE WITHOUT DIFFICULTY. PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO PACU IN STABLE CONDITION. IT WAS NOTED THAT THE TIP OF THE NEEDLE ON THE ARCPOINT SYSTEM BROKE WHILE SAMPLING THE MASS AND THE TIP OF THE NEEDLE WAS LEFT INSIDE OF THE LARGE LEFT UPPER LOBE MASS. PATIENT WAS EVALUATED BY THE NURSE AND THORACIC SURGERY AND THEY AGREED LEAVING THE NEEDLE IN PLACE WITH ITS LOW LIKELIHOOD OF MIGRATION WAS A LESS RISKY OPTION "THAT" EXPLORATORY APPROACH. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8250315 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ENB PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PATIENT HAD A LUNG NODULE LOCATED ON THE DIAPHRAGM AND WAS CONSULTED BEFORE THE CASE ON HIGHER RISK FOR PNEUMOTHORAX COMPLICATION DUE TO LOCATION. THE SUPER DIMENSION OF THE CASE WAS COMPLETED. A CHEST TUBE WAS INSERTED AND THE CHEST TUBE WAS REMOVED LATER THAT AFTERNOON, SO THE PATIENT HAD A COUPLE ADDITIONAL HOURS OF RECOVERY TIME. THERE WAS NO ISSUE WITH THE DEVICE REPORTED.

  Patient problems: Pneumothorax

  MAUDE report 7780464 ↗