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

Model Number 471405-06

Device Problems Break (1069); Unintended System Motion (1430); Difficult to Remove (1528)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.The referenced force bipolar instrument will not be returned for failure analysis.Although the complaint was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the force bipolar instrument moved non-intuitively and could not be removed from universal surgical manipulator (usm) arm 4.The customer received phone assistance from the technical support engineer (tse).Prior to the phone call, the customer used instrument release kit (irk) and then removed the instrument with the cannula together.The customer used a backup instrument to continue with the procedure.The tse reviewed the system logs, found error 31009 and explained that the issue was due to engagement issue.The procedure was continued as planned with no reported injury.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.The movement of the instrument was allegedly not smooth.The instrument could not be removed through the cannula because the wrist of the instrument was broken, and could not be straightened.Therefore, the instrument was removed with the cannula together.Surgical port incision was not increased.There was no fragment that fell into the patient¿s anatomy.The instrument jaws were not stuck on the patient¿s tissue when the issue occurred.The instrument will not be returned foe evaluation.

• 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: 18523690
• MDR Text Key: 333478908
• Report Number: 2955842-2024-10350
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K11221212
• 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,Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2023

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 0252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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