MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number 480440-05

Device Problem Failure to Deliver Energy (1211)

Patient Problem Fluid Discharge (2686)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined as the synchroseal instrument was discarded by the site and is not available for evaluation.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Additionally, all instruments used in the case were used in subsequent procedures with the exception of the cadiere forceps (which was on its final instrument usage) and a site review shows no complaint filed against the instruments.System logs were reviewed by an intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and there were no errors suggesting an instrument failure.There were 22 ¿high initial starting impedance¿ messages logged, indicating the impedance of the tissue between the jaws was higher than expected.This error message is typically due to clinical/technique reasons.The large number of these error messages suggests the surgeon may have been sealing multiple times in the same locations.Additionally, a ¿seal electrode shorted¿ message was recorded approximately 5 minutes after the start of instrument use, indicating the generator detected a short between the seal electrodes.This message suggests the surgeon may have grasped a conductive or metal object (clip/staple/etc.) or activated seal with the jaws submersed in conductive fluid.With both of these messages, energy activation will be interrupted.The user will see a message similar to ¿hemostasis may be compromised¿, ¿incomplete seal cycle¿ or ¿inspect for excess fluid or metal object¿, which may have led them to believe the instrument sealing was unsatisfactory.No image or video clip for the reported event was submitted for review.This complaint is reportable due to the following: after a da vinci-assisted right pulmonary lobectomy procedure, the patient developed a postoperative right chylothorax.The customer reported that they did not injure the thoracic duct during the procedure.The surgeon commented that the sealing of the synchroseal may have been insufficient although they did not specify which structure or vessel had the insufficient seal.The patient was hospitalized and is under observation.It is unknown if any medical/surgical intervention was taken.The procedure was completed as planned.The system log review did not show any events that would suggest a product issue.A review of the logs by an isi afa engineer did not detect any instrument failure.This complaint is considered a reportable malfunction due to the following conclusion: the synchroseal instrument reportedly did not sufficiently complete a seal in synch mode.Per the description of the complaint, the instrument may have incurred a failure mode that is known to impact sealing effectiveness with no claim or evidence of mishandling/misuse.Additionally, the patient developed a chylothorax which required hospitalization.Prolongation of hospitalization is a medical intervention to preclude permanent impairment, and thus, this complaint is a reportable adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that after a da vinci-assisted right pulmonary lobectomy procedure, the patient developed a postoperative chylothorax.The surgeon commented that the sealing of the synchroseal may be unsatisfactory.The patient was hospitalized and under observation.It is unknown if any medical/surgical intervention was taken.The procedure was completed as planned.On (b)(6) 2021, intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr), who spoke to the customer, and obtained the following information: the system, instrument and accessory were inspected before use and there was nothing out of the ordinary.There was no malfunction of an isi system, instrument or accessory that occurred.There was no evidence of insufficient sealing/cautery issue/intra-operative complication observed during the procedure and the surgery was completed as planned.There was no unexpected bleeding observed during the procedure.The customer confirmed that the tissue bundle was less than 5 mm, the tissue fit in the jaws of the instrument, there was no tissue tension, no contact with hard material, no evidence of vessel calcification and the instrument jaws were not contaminated with biodebris or immersed in liquid during the sealing process.There were also no errors seen on the system during the procedure.The patient developed right chylothorax post-operatively which required prolonged hospitalization.The customer reported that they did not injure the thoracic duct during the procedure.Although the patient had swollen lymph nodes, the surgeon suspect that the sealing of the synchroseal was insufficient.It is unknown if the patient was admitted to the icu or underwent medical intervention due to the complication.Photographic images/video of the procedure was not available.Demographic information/relevant investigation and pre-existing medical illness were enquired but not provided.The synchroseal instrument has been discarded by the site.On 07-jul-2021, isi followed up with the csr who spoke to the customer, and obtained the following information: the synchroseal was used to seal the lymphatic vessels during the procedure.Typically, bipolar energy is used to seal lymphatic tissue.

• Brand Name: DA VINCI ENERGY
• Type of Device: SYNCHROSEAL
• 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: 12187549
• MDR Text Key: 262160716
• Report Number: 2955842-2021-10818
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)220930(10)L90200927
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440-05
• Device Catalogue Number: 480440
• Device Lot Number: L90200927 0112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES