MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2024

Event Type  Injury  

Event Description

It was reported that the day after a da vinci-assisted radical extraperitoneal prostatectomy with lymphadenectomy procedure, a port site burn was noted while the patient's dressings were changed.The port site in question was the site where the monopolar curved scissors (mcs) instrument was in use.The severity of the burn, any medical interventions required, and the patient's status are currently unknown.It is also unknown if the mcs instrument was involved in the reported event.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.

Manufacturer Narrative

Based on the current information provided, the cause of the postoperative complication cannot be determined.No product has been returned to intuitive surgical, inc.For evaluation.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument associated with this complaint, and a failure analysis (fa) investigation was completed.Fa did not replicate nor confirm the customer reported complaint.A visual inspection did not reveal any damage.The instrument was placed and driven on an in-house system, where it passed the recognition and engagement tests.The instrument moved intuitively, with full range of motion in all directions, and the tips opened and closed properly.The instrument released energy.No arcing or thermal damage was observed.The instrument was fully functional, and no product issue was identified.Issues related to instrument errors or to complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 18640232
• MDR Text Key: 334542429
• Report Number: 2955842-2024-11038
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K220023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: K15230108 0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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 Sex: Male