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

Model Number 480422-01

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.The product has not been returned to intuitive surgical, inc.(isi) for evaluation.A review of the advanced instrument log for the vessel sealer extend instrument associated with this event was performed by an isi failure analysis engineer (fae).Per the fae, there were no device logs available for this instrument.No integrated electrosurgical unit logs are available, as an erbe vio dv generator was used with this instrument.There do not appear to be any vse related errors in the system logs.

Event Description

It was reported that during a da vinci-assisted lower right pulmonary lobectomy procedure, the vessel sealer extend (vse) instrument did not completely seal the target vessel, resulting in unexpected bleeding.At the time of the event, the surgeon was ligating and dividing the right lower lobe segmental (s6) pulmonary artery.The surgeon approached the segment 6 artery anteriorly and positioned the vse to take the vessel.He pressed the blue pedal to seal the vessel and then double-tapped the yellow pedal.Nothing was observed that would indicate insufficient sealing before the surgeon proceeded with the division of the vessel; the surgeon stated that the tissue was cut following the impression that a complete seal was achieved, including after the "seal completed" tones were heard for that seal attempt.At the time of the event, during the sealing sequence, audible signals were as expected, as they were throughout the instrument use.The surgeon could not remember if the seal cycle complete fast audible tones were heard, but he did not think anything sounded wrong at the time of the procedure.No errors were recorded when the issue occurred.However, only the distal end of the artery sealed, resulting in an immediate high-pressure bleed from the proximal end of the vessel.The surgeon quickly compressed the vessel with one of the universal surgical manipulators and then a swab.After several minutes, a weck clip was successfully applied to resolve the bleeding; however, due to the location of the clip and the subsequent need for tissue manipulations and parenchymal stapling near the area, extra care and time were devoted to avoiding accidentally dislodging the clip.The estimated blood loss as a result of this issue was recorded at 50ml in the suction bottle, plus the volume of blood in 2 wet patties.The patient reportedly recovered well, with no associated adverse effects, and they were discharged on postoperative day 3.The patient did not suffer any morbidity from the instrument failure.The procedure was completed, with no need for a conversion to a thoracotomy.No post-operative complications occurred.The surgeon chose to use the vse instrument, as the space was too small for a sureform staple; the tumor extended from the lower lobe to the upper lobe, it was close to the vessel, and the patient had fused fissures, which did not allow for stapler access.This may have meant that the vessel was under some tension during the sealing/cutting process, however, care was taken to relieve any unnecessary tension prior to proceeding with the use of the vse, and the tension during use would have been within the expected range for a successful sealing.Per a preoperative computed tomography scan, the segment 6 artery was 5.8mm in diameter.There was no evidence of vessel calcification, the tissue was not exposed to any radiation or chemotherapy prior to the procedure, and the jaws did not come into contact with a clip, suture, staple, or other metal objects when the reported issue was noted.The jaws were not immersed in liquid at any time; however, the vse had been previously used during the procedure, and the possibility of residual carbonized tissue could not be excluded.The surgeon could not remember any presence of tissue in the jaws, however, he could confirm that the jaws had not been wiped clean at any time during the procedure prior to the instrument failure.The surgeon could not be entirely sure what caused the vse issue, however he would consider the following 3 factors as contributing issues: the vessel diameter, the relative tension of the vessel, and the possibility of jaw contamination by carbonized tissue.The procedure was delayed by 30 mins in absolute numbers, however, the surgeon stated that the failure of the instrument had an overall effect on his confidence to proceed with further use of the instrument and in how tissues were handled from the moment of the failure onwards.The standard operating room procedure was followed regarding the inspection of the instrument prior to use, and no damage or anything out of the ordinary was reported by the or staff.The instrument had been used before on a small vein and had performed as expected.It was also used at the end of the procedure during station 4r lymph node dissection, on fat tissue, and on small feeding vessels, with no issues.The vse use times were recorded as follows: 28 mins, 47 mins, 1hr 14 mins, 1hr 20 mins, 1hr 23 mins, 1hr 31 mins (failure), 2hrs 5 mins, 2hrs 30 mins.

• 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: 18253037
• MDR Text Key: 329549448
• Report Number: 2955842-2023-20754
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L84230609
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/04/2023

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: L84230609 0182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.