PlanPoint 380718Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874116272), received between Dec 1, 2022 and Nov 1, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED ASYSTOLE. THE PATIENT HAD A MEDICAL HISTORY OF: CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), DEEP VEIN THROMBOSIS (DVT), HYPERTENSION, PERIPHERAL VASCULAR DISEASE, AND CONGESTIVE HEART FAILURE. AS THE PHYSICIAN WAS PERFORMING A RIGHT UPPER LOBE BIOPSY WITH A 21G NEEDLE AND FORCEPS, THE ANESTHESIOLOGIST NOTICED THAT THE PATIENT'S HEART RATE DROPPED INTO THE 40S. IT WAS REPORTED THAT THERE WAS AN EXTREME TIP BEND THAT THE PHYSICIAN WAS ATTEMPTING TO NAVIGATE THROUGH IN ORDER NOT TO DAMAGE THE CATHETER WHEN THE EVENT OCCURRED. THE PATIENT WENT INTO ASYSTOLE AND WAS NOTED TO HAVE A CARDIAC ARREST WHEN THERE WAS NO PULSE ON EXAMINATION. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND EPINEPHRINE WAS PROVIDED; THE CODE LASTED A FEW MINUTES, AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PHYSICIAN BELIEVED THE EVENT WAS NOT RELATED TO THE ION PROCEDURE BUT LIKELY DUE TO THE EFFECTS OF ANESTHESIA AND THAT THE SAME EVENT COULD HAVE HAPPENED WITH ANOTHER BIOPSY MODALITY. THE PATIENT WAS EXTUBATED IMMEDIATELY AFTER THE PROCEDURE AND WAS ADMITT

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 20586402 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE PATIENT'S MEDICAL HISTORY INCLUDES COPD, LUNG CANCER, AND CURRENT SMOKER. THE BIOPSIED LESION WAS 9 MM AND IN THE RIGHT MIDDLE LOBE. THE DISTANCE TO THE PLEURA WAS 1CM. A PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURE VIA CHEST X-RAY. THE PNEUMOTHORAX WAS 1.5CM IN SIZE AND DID NOT INCREASE OVER TIME, AND THE PATIENT WAS ASYMPTOMATIC, BUT THE PHYSICIAN OPTED TO PLACE A CHEST TUBE. NO MEDICATION OR OXYGEN WAS PROVIDED. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND DISCHARGED HOME IN STABLE CONDITION. PER THE PHYSICIAN, THE ION SYSTEM DID NOT CONTRIBUTE TO THE PNEUMOTHORAX, AND A PNEUMOTHORAX MAY HAVE OCCURRED WITH ANOTHER BIOPSY MODALITY. THERE IS NO ALLEGATION THAT AN ION SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION OCCURRED.

  Patient problems: Pneumothorax

  MAUDE report 16812016 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT. THE PHYSICIAN BELIEVED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Pneumothorax

  MAUDE report 16429334 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND ADMISSION TO THE HOSPITAL FOR OBSERVATION. THE PNEUMOTHORAX WAS IDENTIFIED VIA A POST-PROCEDURE X-RAY. PER THE PHYSICIAN, THE ION PROCEDURE DID NOT CAUSE THE PNEUMOTHORAX, BUT IT OCCURRED BECAUSE THE BIOPSY WAS A HIGH-RISK PROCEDURE AND A PNEUMOTHORAX IS A KNOWN COMPLICATION OF THE BIOPSY PROCEDURE. THE INITIAL SIZE OF THE PNEUMOTHORAX WAS 5-10% BUT INCREASED IN SIZE, PROMPTING THE CHEST TUBE PLACEMENT. THE SIZE OF THE LESION WAS 2.3 CM AND THE LESION WAS LOCATED IN THE LEFT UPPER LOBE, LINGULA ON THE FISSURE. THE DISTANCE OF THE LESION TO THE PLEURA WAS 1.4 CM. THE PATIENT WAS HOSPITALIZED FOR A "SHORT STAY" AND WAS DOING WELL. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

  Patient problems: Pneumothorax

  MAUDE report 15899146 ↗