MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MARYLAND BIPOLAR FORCEPS

Model Number 420172-18

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps (mbf) sparked after the instrument was used 70 minutes.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the maryland bipolar forceps (mbf) instrument was inspected prior to use with no issue.The customer confirmed that arcing event occurred and there was no thermal damage to the instrument after arcing event.The arc grounded around the base of the jaws without being scattered.The event occurred when the surgeon was cauterizing the tissue.Bipolar energy was activated when the event occurred, and the instrument was connected properly.The settings were the followings: bipolar soft, effect 4.Moreover, the customer was using mbf instrument on the left hand, mbf instrument on the right hand and the prograsp forceps (pf) instrument when the arcing event occurred.The mbf instrument tips did not collide with any other instrument or contact with the patient¿s tissue when the arcing event occurred.There was no patient injury.The patient did not return to the hospital due to experiencing any post-surgical complications as a result of the arcing event.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have charring and localized melting of both bipolar yaw pulleys, in the space between the grips.The instrument failed the electrical continuity test.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 18706142
• MDR Text Key: 335380094
• Report Number: 2955842-2024-11405
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10230706 252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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