MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CADIERE FORCEPS

Model Number 471049-08

Device Problem Difficult to Remove (1528)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) has received the cadiere forceps instrument for evaluation, but the failure analysis testing has not yet been completed.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer was unable to remove the cadiere forceps instrument from the universal surgical manipulator 1 (usm1) due to the instrument tip becoming stuck at the cannula.The system prompt for "arm not ready" was displayed at the time of the issue.The customer received phone assistance from the technical service engineer (tse).The customer was advised to either manually remove the cadiere forceps instrument using additional force or to remove the instrument with the cannula simultaneously.The user observed a plastic coming out of the joint when the instrument was forced back by hand.The user completed the procedure using the backup instrument with no further issue reported.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: it was clarified that the defective instrument involved with the complaint was the cadiere forceps instrument.There was no damage or anything out of the ordinary that was noted prior to use.The surgical port incision was not increased in order to remove the cadiere forceps instruments and the cannula together.There was no instrument or tool collision.No fragment fell inside the patient.No known impact or patient consequence was reported.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps was analyzed and the complaint regarding cadiere forceps was not confirmed by failure analysis.Failure analysis (fa) investigations did not replicate or confirm the customer reported complaint.Visual inspection was conducted by fa which displayed no signs of physical damage.The cadiere forceps instrument was placed and driven on an in-house system.The cadiere forceps instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions.The grips opened and closed properly.The cadiere forceps instrument grasped and released without any issues on multiple attempts.The cadiere forceps instrument was fully functional.There was no problem detected.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.

• Brand Name: ENDOWRIST
• Type of Device: CADIERE 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: 17209305
• MDR Text Key: 317949572
• Report Number: 2955842-2023-16642
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119778
• UDI-Public: (01)00886874119778(10)K11211025
• 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
• Report Date: 05/29/2023

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: 471049-08
• Device Catalogue Number: 471049
• Device Lot Number: K11211025 0473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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