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

Model Number 480422-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted hysterectomy - benign surgical procedure, the vessel sealer extend (vse) was smoking black while on tissue and continued smoking black after it was removed from tissue with nothing on it.The intuitive surgical, inc.(isi) clinical sales representative (csr) was present and stated to remove the device.The surgeon continued the procedure without using a vse.The procedure was completed as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage or anything out of the ordinary.There was no damage to the instrument noted after the smoking event.The cannula was inspected prior to use.A pin gauge was not used to inspect the cannula.The smoke appeared to originate from the device.There was no arcing observed.There was no thermal damage observed.The surgeon was dissecting when the smoking event occurred.The instrument was connected properly.They used the vessel sealer option on the generator.The instrument was in use 20 minutes or more prior to the event.It is unknown what other instruments were in use.The instrument tips did not collide with any other instrument or tool during procedure.The instrument tips were in contact with tissue when the issue occurred.After it was removed it continued smoking black.The instrument did not touch any staples, clips or sutures while energized.The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.It is unknown what caused the event.There was no injury to the patient noted.The patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.The instrument was returned.There are no photographic images of the device or video recordings of the procedure available for isi review.

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer extend was analyzed and the complaint was not confirmed by failure analysis.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument cut and sealed on 2 of 2 attempts with no issues.There were no sign of black smoke.An electric continuity test was performed and passed.The instrument was fully functional.Additional observations not reported by site: the instrument was found to have dislodged blade.Visual inspection showed that the blade was exposed outside of the blade garage 0.098".No conductor wire damage or snake wrist damage was found.There was not a substantial amount of bio debris found at the instrument tips.Review of the log did not verify any failures.The blade was manually retracted and placed and driven on an in-house system.The instrument was found to have foreign particles on the grips-tips.The foreign particles were removed from the grips using a tweezer.The particles appeared to be small pieces of plastic.Visual inspection displayed no signs of physical damage to the grips-tips.

• 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: 18681010
• MDR Text Key: 335044888
• Report Number: 2955842-2024-11087
• Device Sequence Number: 1
• Product Code: NAY
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: K16230727 01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 25 YR
• Patient Sex: Transgender
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White