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

Model Number 480422-01

Device Problem Insufficient Information (3190)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The vessel sealer extend (vse) was analyzed and found to have the grips stuck in a fixed open position.The instrument grips would not close all the way when manually activated and barely opened with manual input of the thumb lever.The housing was removed, and cable assembly was intact; however, the set screw that holds together the torsion spring and the slug was observed to be stripped.Due to the loose set screw, the torsion spring's range of motion was restricted which kept the jaws from moving normally.During in-house testing the vse did not pass self-test during the initialization process.The vse passed the knife slot and ceramic dot verification.

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, the vessel sealer extend (vse) was reported to have ¿stopped working midway through procedure.¿ the vse was removed from the field, tagged and sent to sterile processing to be addressed.It was not noted if a new device was opened to replace the faulty vse.There were no deviations in care and no harm to patient caused.Intuitive surgical, inc.(isi) followed up with the reporter in an effort to obtain additional information regarding problem instrument had; but the reporter stated they had no additional information to provide.On 05-september-2023, isi received mw5144867 for same reported event.Evaluation of the returned device identified a failure mode that may impact sealing effectiveness.

Manufacturer Narrative

Section d4 (lot #): corrected information.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18107854
• MDR Text Key: 328650081
• Report Number: 2955842-2023-20187
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L84230519
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L84230519 0183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American