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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, that it was tough to remove a force bipolar instrument from the patient.The customer further stated that the metal piece on the force bipolar instrument kept popping out and they had to use a prograsp forceps instrument to straighten it and remove it from the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following information: she stated the robotics coordinator informed her that the instruments were all inspected before inserting into the patient and no damage was noted.The instrument and cannula were removed together the first time it happened because the end of the force that attaches the tip to the handle was out and kept getting hooked on the end of the cannula.The surgeon attempted to straighten the tip out so the hook would be inside the handle, but the hook would not go back in.The instrument had a dislodged pin that prevented them from removing it through the trocar.As such, the surgeon had to use a prograsp forceps instrument to straighten the force bipolar instrument in order to get it out through the trocar.The caller stated they were able to remove both cannula and instrument without causing any damage to the insertion site.There was no collision with other instruments during the case.During the time of the issue, the surgeon was only using the force bipolar instrument and the monopolar curved scissors instrument.The force bipolar instruments jaws were not stuck in the closed position.The surgeon stated that the instruments were moving properly.No fragments of the force bipolar instrument fell into the patient as far as they saw.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved in this complaint, but failure analysis has not yet been completed.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The force bipolar instrument was analyzed and the reported failure was neither replicated nor confirmed.Visual inspection displayed no signs of physical damage to the metal grip.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument attached to and released from the system without any issues on multiple attempts.The instrument was fully functional.There was no problem detected.An additional observation not reported by the site was identified.The instrument was found to have conductor wire insulation damage.The conductor wire was found to have insulation damage inside of the grip routing.Visual inspection found the wire to not be exposed.The instrument grips were manually manipulated, and the instrument passed an electric continuity test on 3 of 3 attempts.There were no signs of thermal damage.The complaint was not confirmed by failure analysis.

• 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: 17244046
• MDR Text Key: 318551969
• Report Number: 2955842-2023-16753
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K12221009
• 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: 06/01/2023

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: K12221009 0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: Black Or African American