MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 471405-06

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the force bipolar (fb) could not be removed because the rear end of the jaw popped out and was stuck with the cannula.The procedure was completing as planned with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the force bipolar instrument was inspected prior to use with no issue identified.The instrument was removed along with the cannula due to physical damage on the instrument.The size of the port incisions was not increased.Prior to attempting to remove the instrument, the instrument jaws were not stuck in a closed position.There was no fragment that fell inside the patient¿s anatomy.The instrument collided with the other instrument during the procedure.The instrument jaws were not stuck on tissue when the issue was identified.There was no procedure delay.The force bipolar instrument has been returned for failure analysis investigation.However, as of the date of this report, the investigation has not yet been completed.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the reported complaint.The instrument was found to have a segment of the conductor wire sticking out near the grips.The instrument was placed and driven on an in-house system.The instrument passed recognition, engagement, electrical continuity, and energy delivery tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.No signs of thermal damage were observed.Further inspection found the conductor wire insulation to be damaged at the distal end.The internal wires were exposed.There was no missing material.In addition, dried residue was also observed around the clamping pulley cable groove.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 18294507
• MDR Text Key: 330566762
• Report Number: 2955842-2023-21041
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• 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,Followup
• Report Date: 11/16/2023

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K11221212 0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 01/05/2024
• Supplement Dates FDA Received: 12/19/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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: Female