MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-38

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pleural Effusion (2010)

Event Date 05/13/2021

Event Type  Death  

Manufacturer Narrative

This event is being reported due to the following conclusion: after undergoing a da vinci-assisted pulmonary wedge resection procedure, the patient experienced a lung leak and ultimately expired.Although the surgeon reportedly alleged that a possible staple line leak had occurred, the cause of the patient¿s post-operative complication and subsequent death are unknown.A review of the site's complaint history does not show any additional complaints related to this product or this event.No products are expected to be returned for failure analysis.No images or procedure videos were provided for review.The instrument logs were pulled for all instruments used during this procedure.It was observed that all instruments were reused in subsequent procedures except for the curved-tip stapler 30 (which had 48 uses remaining) and the suction irrigator which is single-use.The system logs of this procedure were pulled and reviewed and the following was observed: no relevant errors were observed during this procedure.A senior failure analysis engineer reviewed the stapler logs for the stapler used in this event and the following info was provided: this stapler fired a total of two reloads (both green).The logs indicated both firings were completed with no incomplete clamps during the procedure.A medical review was performed by an isi medical safety officer and the following was provided: "air leak is a common complication after pulmonary wedge resection reported as high as 50%.Prolonged air leaks, air leaks that persist for longer than 5 days may occur in up to 18 to 26% of patients.Patients who suffer from emphysema and other underlying lung disease are at significant risk for the development of a prolonged air leak.Air leaks may occur because of tearing of the lung caused by the surface tension between the parallel staple lines.This may be exacerbated in staples are not long enough resulting in an inadequate seal or staples to be pulled through the tissue.Typically, staple heights associated with blue and green staple loads are used to staple lung parenchyma.Additional risk factors for the development of a prolonged air leak after pulmonary surgery are age greater than 65 years, presence of pleural adhesions, fev1 less than 80% and a bmi less than 25.5 kg/m2.The surgeon in the above case seems to have used an appropriate height staple cartridge to perform the pulmonary resection.Based upon the information provided in the description of events and stapler log, it is reasonable to conclude that the patient developed an air leak at the staple line as part of common complication of the procedure that was not caused or contributed by the da vinci system, instrumentation, and/or accessories.Due to decline in the patient¿s overall health after the pulmonary wedge resection, care was withdrawn and the patient expired." this event is being reported as an adverse event because the patient reportedly experienced a lung leak and ultimately expired.Although the surgeon reportedly alleged that a possible staple line leak had occurred, the cause of the patient¿s post-operative complication and subsequent death are unknown.Blank mdr fields: follow-up was attempted, but the patient information for field was not provided.The expiration date for section is not applicable.Field implant date is blank because the product is not implantable.Information for the blank fields in section initial reporter name and address is not available.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields pma/510k, recall (if recall number is given) or correction/removal number (if given), and correction/removal number are not applicable.

Event Description

It was reported that after a da vinci-assisted wedge resection surgical procedure, the patient expired while hospitalized.The patient first underwent an ion procedure to place dye at the target lesion in the left lower lobe of the lungs.An ion 19g needle was used to insert the dye.A scheduled wedge resection procedure was performed after the ion procedure.The procedure was reportedly completed with no reported issues, but the patient was hospitalized and eventually moved to the intensive care unit (icu) about one week post-operation.The surgeon believes that there might have been a staple line leak as the patient had a collapsed lung and did not recover.The patient reportedly expired.Follow-up: on 16-june-2021, intuitive surgical inc.(isi) contacted the site intuitive surgical, inc.(isi) endoluminal territory associate (eta) and additional information was obtained about the event: the eta was present for the ion portion of the procedure.The ion was only used to place dye in the left lower lobe of the lungs.The procedure moved to a planned da vinci assisted wedge resection.The isi clinical sales representative (csr) was present for the beginning of the da vinci procedure and then left.The ion and the da vinci procedures were performed by the same surgeon.After the da vinci wedge resection, the patient was hospitalized with three valves placed to control a leak.The site had difficulty removing the et tube and the patient did not recover from the procedure.The patient¿s family chose to remove the tube and patient expired.The surgeon said he does not believe the patient¿s death was related to the ion nor the da vinci system and products.Follow-up: on 16-june-2021, isi contacted the site eta who had spoken to the surgeon of this procedure and additional information was obtained about the event: a chest tube was placed immediately after the wedge resection procedure as a lung leak was noticed.It is unknown how the site first became aware of the lung leak.The patient was hospitalized with the chest tube following the wedge resection.Seven days post-op, on (b)(6) 2021, the chest tube was replaced with three valves and the patient was moved to the icu as they were not recovering from the lung leak.The patient and their family decided to end the patient¿s life by ending the intensive care on (b)(6) 2021 (eleven days post-op).No autopsy has been performed at this time.The surgeon reported that they documented the cause of death as "natural causes/old age".The patient was reported to have a history of emphysema and to be a previous smoker.The surgeon reported that there were no errors during the wedge resection procedure and no issues with the stapler or staple lines.The surgeon said this event would have likely occurred via another modality.The surgeon did not have a root cause of why the lung leak occurred.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just an adverse event as previously reported due to the report of postoperative leak and subsequent death, which could potentially be related to a product problem.Corrected information can be found the following fields: b1, annex e, annex f, annex a and annex g.B1 updated from "adverse event" to "adverse event and product problem".Annex e updated to include e0506 due to the report of ¿leak¿.Annex f updated to include f0801 due to the report of ¿moved to the intensive care unit (icu)¿.Annex a updated to include a050704 due to the report of ¿staple line that was bleeding.¿ annex g updated to include g0405214 as complaint is related to the staple.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12055774
• MDR Text Key: 258003607
• Report Number: 2955842-2021-10704
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-38
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White