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It was reported that during an ion lung biopsy procedure, significant intraoperative hemorrhage was encountered and the procedure was aborted.Prior to abortion, biopsy samples were successfully obtained, and the physician was able to establish a diagnosis.Mid-procedure, the ion system experienced a non-recoverable fault, indicated by a red circle alert on the system display.The system shut down completely, rendering the robotic arm non-functional and preventing controlled retraction of the catheter via the wheel mechanism.The fault occurred during acquisition of additional transbronchial biopsy samples for molecular testing.Significant bleeding was present at the time of the system fault.Estimated blood loss was approximately 400-500 ml.The patient required nearly every available bronchoscopic hemostatic intervention, with the exception of argon plasma coagulation (apc).The patient did not require blood transfusion.Following the procedure, the patient was kept intubated in the intensive care unit (icu) with an endobronchial blocker in place due to small, ongoing slow hemorrhage.The physician indicated that the ion system malfunction may have been a contributing factor in the management of post-biopsy hemorrhage.Per his standard clinical practice, a bronchoalveolar lavage (bal) is performed at the biopsy site at the conclusion of ion-guided biopsies.Manual syringe suction is applied while the ion catheter is slowly retracted using the control wheel until fluid return is obtained.In the event that aspirated fluid is grossly bloody, consistent with active hemorrhage, retraction is paused and hemostatic agents are instilled sequentially - cold saline, followed by epinephrine, followed by tranexamic acid (txa) - prior to resuming retraction.Due to the system malfunction, this controlled retraction protocol could not be executed.The physician was required to disconnect the ion catheter from the adapter endotracheal tube, advance the plastic connector, and manually remove the catheter while the robotic arm remained non-functional.Following catheter removal and introduction of the bronchoscope, massive endobronchial hemorrhage was observed.The physician did not attribute the hemorrhage directly to the ion system, noting that bleeding of this nature would likely have occurred regardless of the modality used.The patient had severe pulmonary hypertension, and the hemorrhage was associated with biopsy of tissue within a high-pressure vascular environment.The bleeding source was identified as a branch of the pulmonary artery, likely at the 4th division.The target mass had associated vasculature, which increased the inherent procedural risk.The patient was not on anticoagulation at the time of the procedure.
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Intuitive surgical, inc (isi) did not receive a da vinci product to perform failure analysis.An isi field service engineer (fse) performed site visit, troubleshooting and successfully restored system functionality.A review of the site's system logs for the reported procedure date was conducted.Investigation showed a recoverable emergency stop fault during the second procedure that indicates that the emergency stop button was pressed.According to a systems analyst, the software is designed to display a recoverable message to the user, prevent fine insertion movement (fim) movement via the scroll wheel and trackball, and place the catheter into a limp state.A log review confirmed that the catheter entered the expected limp condition following the error.The system is not designed to shut down as a result of the error alone.Review of the logs indicates the system was subsequently powered off by the user several minutes after the recoverable fault.Based on the timing and reported sequence of events, this error appears to correspond to the physician's description of the reported malfunction.The error occurred after additional biopsy samples were collected and resulted in a loss of robotic motion, consistent with the physician's report that the robotic arm could not be manipulated and that catheter retraction via the wheel mechanism was not possible.There is no evidence of catheter retraction in the available logs, and any retraction that occurred after system power-off would not be captured.However, if the catheter were manually retracted while in the limp state, minimal risk to the patient would be expected because the catheter is no longer actively driven by the system.The systemlog review confirmed no system malfunction.The system operated as designed in response to the user activating the e-stop button, and control of the system was recoverable by simply pressing the e-stop button again.Iisi will follow up with the physician and make them aware of the cause of the error and how to address it.A review of the event was conducted by an isi medical officer and the following additional information was provided: "during ion biopsy procedure in a patient with severe pulmonary hypertension, significant hemorrhage was encountered.The physician reported a device malfunction where there was loss of control over the ion system, and the robotic arm became non-functional.The physician manually removed the ion system and completed the protocol for hemorrhage control with a flexible bronchoscope.On further investigation of the system by ion engineers, it was found that the e-stop mechanism was engaged on the ion system that halts all motorized catheter movements a procedure.The plan is to provide the physician with instructions regarding the e-stop function on ion, including engaging and disengaging the function.No further information is available regarding the procedure and patient outcome.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.Bts guidelines for flexible bronchoscopy recommends to liase with a hematologist regarding need for platelet transfusion for thrombocytopenia prior to bronchoscopic biopsy due to a lack of evidence.Bts guidelines for image guided lung biopsy states that a platelet count of <100k/ml is a relative contraindication for lung biopsy.A small case series of bronchoscopic biopsy in thrombocytopenia recommended a platelet count of <20k/ml as an absolute contraindication due to an increased risk of bleeding.The american association of blood banks has no specific recommendations regarding bronchoscopy but recommends a platelet count of >50k/ml for lumbar puncture as well as for major nonneuraxial surgeries.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.Bo l, shi l, jin f, li c.The hemorrhage risk of patients undergoing bronchoscopic examinations or treatments.Am j transl res.2021.Rand iad, blaikley j, booton r, et al.British thoracic society guideline for diagnostic flexible bronchoscopy in adults: accredited by nice.Thorax.2013.Papin ta, lynch jp, weg jg.Transbronchial biopsy in the thrombocytopenic patient.Chest.1985.Kaufman rm, djulbegovic b, gernsheimer t, et al.Platelet transfusion: a clinical practice guideline from the aabb.Ann intern med.2015.Manhire a, charig m, clelland c, et al.Guidelines for radiologically guided lung biopsy.Thorax.2003"
blank mdr fields:
the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
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