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 06/16/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the surgeon mentioned that the force bipolar instrument "felt weird." the surgeon then could not straighten the tip of the instrument because the hinge on the instrument jaws came off the pivot point.It appeared to resemble a hook and due to that, it was difficult to remove because the ¿hook¿ hinge kept getting caught on the cannula while trying to remove it.The instrument finally came out with the help of other instruments.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the force bipolar instrument associated with this complaint and completed investigations.Failure analysis (fa) investigations could not replicate nor confirm the customer 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 installed and removed from the system several times without any issues.The instrument was fully functional.Additional steps/testing was performed.Visual inspection of the instrument found no physical or cosmetic damage on the distal end.No pins were dislodged or missing.No cables or wires exhibited any signs of fraying, breakage or insulation damage.The housing was removed from the back end, no damage was found.An electrical continuity test was performed and passed.An energy delivery test was performed while the instrument was installed on an in-house system and passed.There was no problem detected.A review of the instrument log for the force bipolar instrument (471405-06/k10220124 0144) was performed.The instrument was last used on (b)(6) 2022 on system sk3089.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: the instrument was difficult to remove from the cannula due to a unknown loose component or loose pin.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.

• 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: 15036901
• MDR Text Key: 304530277
• Report Number: 2955842-2022-13023
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10220124
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2022
• 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: K10220124 0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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