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 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed/replicated the reported complaint.The instrument was found to have a frayed grip cable at the distal idler pulley.The frayed cable strands stuck out at the wrist.The pulleys exhibited no damage.Other cables were not damaged.The housing was removed from the back end, no damage was observed.The root cause of frayed - distal instrument grip cables is attributed to a component failure.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: n10200817-0194) associated with this event has been performed.Per logs, the instrument was last used on march-08-2022 on system sk0803.The instrument was used for 21 minutes.The instrument had 4 uses remaining out of 12 max 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 broken hinge.Jaw dislodgment could result in the tips being stuck and unable to be opened with master tool manipulator (mtm) activation or instrument release kit (irk) use or for a fragment to fall inside the patient.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.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the hinge of the force bipolar instrument broke inside the patient.The customer had to remove the trocar along with the instrument because the instrument was stuck inside the trocar.No fragment fell inside the patient.The customer used a backup instrument.The procedure was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter (spd lead) and obtained additional information: the instrument was inspected prior to use with no damages noted.The surgeon was in the abdomen trying to grasp an organ when the reported issue occurred.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The hinge broke and the or staff attempted to remove the instrument.The instrument went inside the trocar normally, but it broke inside the trocar.The trocar had to pull out along with the instrument.There was no patient harm/injury.

• 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: 14069083
• MDR Text Key: 298570060
• Report Number: 2955842-2022-10992
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N10200817
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• 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: N10200817 0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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 Sex: Female