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

Model Number 471405-06

Device Problem Difficult to Remove (1528)

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

Event Date 01/18/2024

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.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 instrument tip failed to close properly during removal attempt.The instrument got stuck within the port and was unable to be pulled out properly.The user contacted the technical service engineer (tse) for phone assistance.The user received instructions on how to remove the instrument.Additional report confirmed that the instrument was removed with the cannula on universal side manipulator (usm) arm 1 due to a bent instrument wrist.Following this, the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: the instrument was inspected prior to use and there was no damage or anything out of the ordinary.There was no system fault.The jaws of the instrument were not stuck on tissue.There was no unexpected tissue removal.There was no bleeding.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument failure analysis.The force bipolar instrument was found to have a bent grip tip.A 0.003¿ offset at the base of the grips caused the instrument to become lodged on the outside of the cannula was confirmed.The grips did not show cracking damage.Furthermore, components adjacent to this bent grip did not show damage.When the tips of the instrument grips are misaligned/bent, this issue would be visually detectable.Furthermore, a loss of cautery would be detected with a lack of tissue effect at the end effector.Grip bending is related to the application of torque relative to the opening of the instrument grips.High loading of the tip with the grips open can cause damage to the grips, with longer grips being more susceptible to failure.The complaint was confirmed by failure analysis.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18699975
• MDR Text Key: 335301660
• Report Number: 2955842-2024-11394
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: K10230219 0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: Female