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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the force bipolar instrument to perform failure analysis.At the time of this report, failure analysis has not been completed.A follow-up mdr will be submitted after failure analysis investigation.

Event Description

It was reported that during a da vinci-assisted umbilical hernia tapp surgical procedure, the tip of the force bipolar instrument was bent.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use.The instrument did not collide with another instrument or tool.There was difficulty removing the instrument through the cannula due to the misaligned jaw.The port incision was not increased to remove the instrument.The joint was misaligned.The instrument's jaws were not stuck in a closed position prior to removal.There was no tissue stuck between the jaws.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed, and the failure was replicated and confirmed.The instrument was found to have a bent grip, causing misalignment of the grips.There was a.0245¿ offset at the tips.The grips did not show cracking damage.Components adjacent to this bent grip did not show damage.Additionally, isi received a video clip related to the alleged complaint.A review of the video clip was conducted by the cde team.The following additional information was provided: for the first 12 minutes of this video, we see the surgeon using the force bipolar instrument in arm 1, a monopolar cautery hook in arm 3 and an assistant laparoscopic grasper to open up the peritoneum and attempt to reduce the umbilical hernia sac.The surgeon used the force bipolar to forcefully pull down on the incarcerated tissue multiple times while at a full wrist as well as collided the wrist multiple times with the lap grasper.It is unclear when exactly the force bipolar bends but the most obvious moment that something has broken is at the 13:00 mark after the force bipolar forcefully shoots off screen after grasping the incarcerated tissue.When the force bipolar returns on screen the damage can be seen and appears to be noticed by the surgeon.The surgeon can no longer use the instrument and attempts to remove it at 13:33 but it becomes stuck in the cannula.The surgeon then attempts to use the lap grasper and the mch to force the instrument through the cannula but does not succeed and removes the entire cannula at 15:31 from the body cavity.The instrument is uninstalled off camera and the cannula is reinserted at 18:22 and a fenestrated bipolar is installed and inserted at 19:18.The video then goes on for approximately another hour and the procedure is completed.Based on the number of collisions as well as the force bipolar frequently going off screen we cannot determine a root cause for this issue.

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: 19160449
• MDR Text Key: 341125117
• Report Number: 2955842-2024-13606
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(11)230928(10)K10230928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: K10230928 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White