MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; SYSTEM CART (2024)

Based on the current information provided, the cause of bleeding cannot be determined.A review of the site's system logs for the reported procedure date was conducted by an isi senior failure analysis engineer.Investigation revealed there were no related system errors to have occurred during the procedure that were relevant to the reported event.A review of the event was conducted by an isi medical safety officer and the following additional information was provided: a 81-year-old patient underwent an ion biopsy of a right upper lobe nodule.Bleeding was noted after obtaining a cryoprobe biopsy.Lavage was performed with 700ml of bloody return.A balloon blocker was reportedly not available in the hospital.2 units of prbc were transfused and the patient was transferred to the icu.A few hours later the patient was successfully extubated.The patient was discharged home after 3 days on 2 lpm of oxygen.Of note the patient was on blood thinners which were reportedly held for the procedure.Attempts at obtaining further information have been unsuccessful.There was no malfunction of the ion system, instruments or accessories.Based on the available data the reported event was procedure related and not device related.Bronchoscopy is a minimally invasive procedure with a low risk profile.A retrospective study of 20,986 bronchoscopies reported 21 episodes of hemoptysis of > 50 ml (0.38%) and 19 episodes < 50 ml (0.34%).A prospective multicenter international study of 1,215 navigational bronchoscopy cases reported a bleeding rate of 2.5% overall and a ctcae grade 2 or greater bleeding rate of 1.5%.A single center retrospective review of 19,017 bronchoscopic biopsies reported a severe bleeding rate of 0.79% with a higher rate in more central lesions.A recent meta-analysis of navigational bronchoscopy in 10,381 patients reported an overall adverse event rate of 5.6% with 1 death.Bleeding of any severity was reported in 2.1% of all cases.Folch ee, pritchett ma, nead ma, et al.Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: one-year results of the prospective, multicenter navigate study.Journal of thoracic oncology.2019.Facciolongo n, patelli m, gasparini s, et al.Incidence of complications in bronchoscopy.Multicentre prospective study of 20,986 bronchoscopies.Monaldi archives for chest disease.2009.Kops sep, heus p, korevaar da, et al.Diagnostic yield and safety of navigation bronchoscopy: a systematic review and meta-analysis.Lung cancer.2023.

It was reported that during an ion endoluminal lung biopsy procedure, the patient experienced bleeding which required medical intervention and hospitalization.The patient was known to be on blood thinners, but they were appropriately stopped before the procedure.The target nodule was less than 1 centimeter in size and located in the right upper lobe close to a blood vessel.During biopsy workflow, the physician used a cryoprobe on the target lesion.When the probe was retracted, bleeding was noted in the endotracheal tube.An emergent endobronchial lavage was performed, and the estimated blood loss was around 700 milliliters (ml).A balloon blocker was not used as there was not one available in the hospital.The specific interventions required to control the bleeding were not reported, but there was a procedure delay of 1 hour.The patient received 2 units of blood and was transferred to the intensive care unit (icu).A few hours later, the patient was extubated.The patient stayed in the hospital for 3 days and repeated chest x-rays showed improved condition.Upon discharge, the patient was prescribed 2 liters per minute of oxygen for home use.The physician reported that the bleeding was not directly caused by the ion procedure.They mentioned that this was a high-risk procedure and bleeding would have likely occurred regardless of the modality used.There was no device malfunction associated with the bleeding event.