MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

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

Event Date 09/10/2021

Event Type  Death  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication has been determined to be the vessel sealer extend (vse) instrument insufficiently sealing the target vessel.It is unknown at this time how the patient expired as the surgeon reported the date of death was one week post-operation.The surgeon of this procedure and one of the site robotics coordinators both said they do not know the location of the vse instrument that was used during this event, and that they both assumed that it was discarded.A review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure.The vse is a single use instrument and therefore was not used in subsequent procedures.An isi failure analysis engineer reviewed the instrument logs for the vse instrument used during this procedure and the following information was provided: this vse instrument was used for 28 minutes and installed on the patient side cart (psc) twice.The vse was used to apply energy 58 times and was used to transect tissue 56 times.The logs indicate that seal complete tones were given for every seal event and no errors occurred.There is nothing in the logs that suggests that an instrument failure occurred.A medical review was performed by an isi medical safety officer and the following information was provided: "the information provided in the description of events indicates that the patient, who underwent a da vinci assisted paraesophageal hernia repair, developed a delayed bleed from a short gastric vessel (noted to be 5 mm in diameter), which resulted in hypotension.The patient expired about one week after the procedure.The cause of the insufficient seal on the short gastric vessel that led to the bleeding event is unknown." this event is being reported based on the following conclusion: it was reported that during a da vinci-assisted procedure a vse instrument insufficiently sealed a vessel that later opened and began to bleed requiring blood transfusions to be administered.The patient was reportedly hospitalized for a week before passing away.

Event Description

It was initially reported that during a da vinci-assisted paraoesophageal hernia procedure that bleeding occurred after the use of a vessel sealer extend (vse) instrument.The procedure was converted to open.The surgeon said they believe the issue was caused by the vse instrument.On 24-sep-2021, intuitive surgical inc.(isi) contacted the surgeon of this procedure and additional information was obtained about the event.The surgeon reported that the cause of the bleed was a possible malfunction of the vse instrument.The reported bleed was noticed because the patient was experiencing hypotension.The tissue that was bleeding was a 5mm large short gastric vessel.It was reported that the only instrument used on this tissue was the vse instrument.It is unknown how much blood was lost, but blood transfusions were reportedly administered.The surgeon reported that it is believed the vse instrument caused and/or contributed to this event because ¿a vessel smaller than 7mm opened up over 45 min after divided by the sealer.¿ it was reported that the vse instrument was working as expected during the procedure for a time.The surgeon reported that he did not observe the vse instrument seal tissue that was identified to be insufficiently sealed, however, the surgeon did report that the vse cut tissue that was not fully sealed.The surgeon reported that the ¿seal completed¿ tones were heard for this seal attempt.No error messages were generated due to this event.The vse instrument did not encounter any staples, clips, or other type of interference during the sealing cycle.The patient was reportedly hospitalized for one week due to this event and ultimately passed away.There are no photos or videos of this event.On 07-oct-2021, the isi clinical sales representative (csr) was contacted and additional information regarding this event was obtained.The csr said he asked the surgeon of this procedure and a robotics coordinator from the site if this vse instrument was available for return and the customers said they do not know where the instrument is and assume that it was immediately discarded.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 12629026
• MDR Text Key: 276335841
• Report Number: 2955842-2021-11302
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L91210425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L91210425 0369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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