MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number 470172-16

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 02/06/2020

Event Type  Death  

Event Description

It was initially reported that during a da vinci-assisted nephro-ureterectomy procedure, the surgeon cut the renal artery using an unspecified endowrist instrument.The case was converted to open surgery and the patient expired.There was no allegation that a malfunction of the da vinci surgical system had occurred.On 20-feb-2019, an intuitive surgical, inc.(isi) representative was contacted and the following additional information was provided after confirmation with the site: the patient expired as a result of surgeon error.Neither the unspecified endowrist instrument, nor the da vinci system, instruments, or accessories caused or contributed to the patient's intra-operative complication and subsequent death.The operating surgeon was "young and unsupervised," and had not completed training held by isi prior to utilizing the da vinci system.The lead surgeon had been informed that formal training by isi must be performed prior to performing surgery using the da vinci surgical system; however, he decided to train the operating surgeon at the site.On 26-feb-2020, isi obtained the following additional information regarding this event based on a conversation between an isi representative and the lead surgeon: the surgical procedure was a nephro-ureterectomy; patient was a (b)(6) male.The operating surgeon was dissecting with an endowrist maryland bipolar forceps instrument in the renal hilum area when the renal artery was cut.The surgeon made a wrong gesture (cut) and moved the instrument around the renal artery without seeing the tip.According to the lead surgeon, the operating surgeon was not well-exposed enough in the "so-touchy" hilum area, and the vision was not 100% secure to move the instrument.The procedure was converted to open surgery to address the transected renal artery.The lead surgeon was called to convert and help in clamping the renal artery with no success.The renal artery was not repaired.The lead surgeon then called the vascular team in emergency.The vascular team tried to clamp the thoracic aorta several times with no success; however, this created a breach in the aorta.An aortic by-pass was performed, but the hemorrhage was "too important." the patient died on the operating table during the open surgery.There is no precise information regarding the estimated blood loss from the intra-operative complication.However, per the lead surgeon, blood pressure in a kidney is around 250 milliliters per minute.The conversion started after 5 minutes, resulting in approximately 3.1 liters of blood at the conversion time.The lead surgeon/site believes that the cause of the patient¿s demise resulted from the following: the renal artery cutting without full vision of the instrument tips, and "it is a following of situations that lead to the patient death." according to the lead surgeon, the patient died "on a metabolic way." the lead surgeon stated that the da vinci is not involved in this death.The lead surgeon takes all responsibility medico-legally.The lead surgeon decided to conduct the following internal actions at the hospital: on (b)(6) 2020, internal training and refreshment on emergency conversion processes will be provided to the all teams of surgeons, first assists, and anesthesiologists.There will be no hilum dissection for new urologists, without the lead surgeon¿s coaching and supervision in the operating room.The maryland bipolar forceps instrument will not be used for renal surgery (they will switch to double fenestrated grasper and force bipolar with dualgrip).On 27-feb-2020, isi obtained the following additional information regarding this event from the isi representative: according to the lead surgeon, the endowrist maryland bipolar forceps instrument / da vinci surgical system did not cause or contribute to the patient's intra-operative complication and subsequent death.The endowrist maryland bipolar forceps instrument was in the surgeon¿s field of view; however, the tip was not in view as the curved portion was covered by the renal artery.Cutting the renal artery is not a planned part of the procedure; the operating surgeon accidently cut the artery in error.No energy was activated when the artery was cut.The hospital will switch to using a double fenestrated grasper or force bipolar with dualgrip for renal surgery to reduce risk of surgical error as the tip is round (so harder to cut an artery).

Manufacturer Narrative

An isi internal medical safety officer provided the following after reviewing the case information: based upon the information provided the cause of death was massive blood loss resulting from an injury to a blood vessel in the renal hilum.Per the record, the surgeon of record was being trained by a colleague at his hospital.During a da vinci-assisted nephro-ureterectomy, the console surgeon injured a blood vessel in the renal hilum.The console surgeon was not being supervised at the time the injury occurred to the blood vessel.The patient then experienced massive blood loss.The procedure was then converted to open.Control of the bleeding was not obtained.The patient then expired.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality.The log review supports the customer claim that there was no system issue during the case.Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: monopolar curved scissors instrument (part #470179-19; lot #n13190729-0020) had zero lives remaining at the end of the procedure and site reviews have shown that no complaints were filed against the instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted nephro-ureterectomy surgical procedure, the surgeon inadvertently cut the renal artery with a maryland bipolar forceps instrument, which resulted in significant blood loss and eventual patient expiration.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14325715
• MDR Text Key: 291194515
• Report Number: 2955842-2022-11452
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N11191111
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N11191111 0198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• 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
• Patient Age: 73 YR
• Patient Sex: Male