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

Model Number 480422

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.No product has been returned to intuitive surgical, inc.(isi) for evaluation.A review of the advanced instrument log for the vessel sealer extend instrument (part #: 480422-01 | lot #: l82230728-0118) associated with this event was performed by an isi failure analysis engineer (fae).Per the fae, the device logs show that the instrument was installed 1 time, and it passed homing 1 time.A total of 119 cut complete events were completed with no errors.The e100 logs show a total of 87 coag events, with no errors, and 174 seal events with 3 high initial starting impedance errors.The system logs show no errors related to the instrument's functionality.The instrument was in use for about 2 hours and 18 minutes.

Event Description

It was reported that during a da vinci-assisted mediastinal mass resection procedure, the vessel sealer extend (vse) instrument became stuck on the pulmonary vein, causing an unspecified injury and bleeding.The surgical task being performed at the time was unknown.The surgeon converted the procedure to thoracotomy to address the bleeding.The estimated amount of unexpected bleeding as a result of this injury was unknown, as was the medical intervention used to control/resolve the bleeding.It was also unknown if any blood transfusions were administered.There was a delay during the conversion process, as the operating room was small, and it took some time to bring in the equipment used for rollout and thoracotomy.It was unknown how much time elapsed between the time the injury occurred to the time the thoracotomy equipment was in place; however, the patient did not experience a serious deterioration or clinical instability due to the delay in converting the case.The surgery was completed successfully.The patient's current status is unknown.It was unknown if unintuitive motion of the vse, and sealing issue with the vse, and/or anatomical factors caused or contributed to the injury.The vse did seal successfully during the procedure; it was unknown how long it was in use prior to the issue.It was also unknown if the instrument was inspected prior to use.It was unknown if any error messages were generated when the event occurred.It was unknown what the surgeon believed caused the issue.Per the reporter, no malfunction of the vse occurred.

• 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: 18787021
• MDR Text Key: 336285177
• Report Number: 2955842-2024-11820
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2024

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
• Device Catalogue Number: 480422
• Device Lot Number: L82230728 0118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.