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

Model Number 471405-06

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.A review of the system logs confirmed that the instrument has nine lives remaining and has not expired.The instrument life indicator remained to show white, indicating that the instrument has not expired.The force bipolar 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 was fully functional.Additional observations not reported by the site were also identified.The force bipolar instrument was found to have a frayed grip cable at the distal end.The frayed cable strands stuck out at the wrist.The root cause of the frayed - distal instrument grip cables is attributed to a component failure.A visual inspection was performed and the instrument distal clevis was found to have mechanical indentations.The root cause of this failure is attributed to mishandling/misuse.A review of the instrument log for the force bipolar instrument (471405-06/k10211129-0012) associated with this event has been performed.Per logs, the force bipolar instrument was last used in a procedure on (b)(6) 2022 via system (b)(4).The alleged instrument had 9 uses remaining after the last procedural use.An event verification confirmed the procedure was performed on the reported event date.A review of the site's complaint history found that there were no other complaints for this product.No image or video of the procedure was provided for review.This complaint is a reportable malfunction event due to the following conclusion: it was alleged that the force bipolar instrument failed to release from a suture and had to be removed through the use of another instrument.Medical intervention may be required in the event that the instrument fails to unclamp/release from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted bilateral inguinal hernia surgical procedure, the force bipolar instrument jaws would not open.The customer had to use the instrument release kit (irk) to open the jaws.The procedure was completed with no reported injury.The force bipolar instrument is a multi-use instrument with bipolar energy capability.This instrument is designed for dissection, grasping, retraction, and bipolar coagulation of tissue.This instrument allows the user to temporarily apply a strong grip mode, depending on surgical needs.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information on 7th april, 2022: the force bipolar instrument was inspected prior to use and no issues were noted.The instrument was functioning normally before the jaws were stuck onto a suture.There were no system errors.The instrument jaws were not stuck on the tissue.The surgeon used the needle driver instrument to break off the suture within grasps of the force bipolar instrument and removed it from the patient without requiring the irk as had been originally noted.There was no impact to patient tissue nor medical intervention required for the removal of the instrument.

• 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: 14233672
• MDR Text Key: 290474395
• Report Number: 2955842-2022-11282
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10211129
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• 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: K10211129 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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