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

Model Number 471405-06

Device Problem Difficult to Remove (1528)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted bilateral inguinal hernia surgical procedure, the force bipolar instrument stopped working.It was very difficult to get the instrument out of the port.The port was taken out of the patient with the instrument to remove it.The procedure was completed with no patient harm.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the force bipolar instrument was inspected prior to use and there was no damage found.The instrument wrist could not be straightened due to physical damage.The instrument jaws were stuck closed.There was no fragment fell into the patient.The instrument collided with another instrument or tool and has been returned for evaluation.

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.An return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed, and the complaint was not confirmed by failure analysis.The instrument was placed and driven on an in-house system.The instrument passed the recognition, engagement, electrical continuity and energy delivery tests.The force bipolar instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Additionally, the instrument was found to have a dislodged conductor wire at the distal end.The instrument was found to have a segment of the conductor wire sticking out from the grips and the wire insulation was damaged.No signs of thermal damage were observed.

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: 18389843
• MDR Text Key: 331583503
• Report Number: 2955842-2023-21721
• Device Sequence Number: 1
• Product Code: NAY
• 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: 12/08/2023

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: K13230608 0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/24/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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.