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 03/24/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the tip of the force bipolar instrument was dislodged and the instrument was stuck inside the port.No fragment fell inside the patient.The procedure was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the instrument was inspected prior to use with no damage noted.The or staff was able to straighten the jaws and remove the instrument from the cannula.The jaws were not stuck on the tissue.A backup instrument was used to complete the procedure with no reported patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis did not confirm/replicate the reported complaint.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 was fully functional.Visual inspection of the instrument found no physical or cosmetic damage on the distal end.The housing was removed from the back end, and no damage was found.The instrument was installed and removed from the in-house system several times and did not experience any difficulty or resistance when removing.An electrical continuity test was performed and passed.Grip management and energy delivery tests were performed while the instrument was installed on an in-house system and passed.There was no problem detected.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the instrument log for the force bipolar instrument (part number: 471405-06, lot number: k12211122-0189) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system sk2737.The instrument was used for 17 minutes.The instrument had 7 uses remaining out of 12 maximum tool uses.No image or video clip for the reported event was submitted for review.This complaint is considered as a reportable event due to the following conclusion: it was alleged that the force bipolar instrument could not be removed from the cannula due to the grip tip sticking out/jaw being dislodged.Jaw dislodgment could result in the tips being stuck and unable to be opened with mtm activation or instrument release kit (irk) use.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 while grasping tissue.Medical intervention may be required in the event that the instrument jaws fail to open from tissue when commanded by the user or system.

• 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: 14227526
• MDR Text Key: 290472566
• Report Number: 2955842-2022-11266
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K12211122
• 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: 04/27/2022
• 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: K12211122 0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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