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

Model Number 470405-06

Device Problem Difficult to Remove (1528)

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

Event Date 07/31/2020

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair, the force bipolar (fb) instrument's jaw attachment was raised up and was unable to be extracted through the cannula.The bedside assistant was finally able to extract from the cannula.There was no fragment that fell into the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the reporter and obtained the following information: the instrument was inspected before usage.The surgeon was grasping tissue when the back of the wrist popped out.There was no broken wire seen at the wrist.The instrument was not able to grasp tissue anymore and the staff tried to remove the instrument, but the part which popped out was stuck on the cannula.The instrument`s wrist could be straightened and the staff was finally able to remove and replace the instrument with a new one and the procedure was completed.There was no collision of the fb instrument with an other instruments nor tools during the procedure; no contact of the instrument tips to clips/sutures/staples when the instrument was energized and the fb instrument was not in the strong grip mode.

Manufacturer Narrative

Intuitive has received the force bipolar (fb) instrument associated with this complaint and completed investigations.Failure analysis (fa) investigation did not confirm nor replicate the customer reported complaint of, "unable to be extracted through cannula." the instrument was checked for recognition and engagement on system.The system successfully recognized and engaged instrument on multiple attempts and on different arms.The fb instrument was driven and moved intuitively with full range of motion in all directions.There was no difficulty in removing or installing the instrument on the system arm.The levers were still present on the instrument and were easily depressed, to remove the instrument during disengagement of instrument with various cannulas.

• 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: 17015997
• MDR Text Key: 316140150
• Report Number: 2955842-2023-15101
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/05/2020

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200330 0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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