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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the failure of broken grip tips.The instrument was found to have a broken grip at the grip base.A piece approximately 0.18" x 0.28" was found to be broken off the yaw pulley.The broken piece was returned with the instrument.No pieces were missing.The root cause of broken instrument grips tip is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws.System log review confirmed that the force bipolar instrument was last used on (b)(6) 2022 with one use remaining on system sk3387.A site history review was performed and no other complaints related to this product were identified.No image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure.At this time it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy the customer had issues with removing the force bipolar instrument was difficult to remove.Customer used emergency halt but still failed to remove instrument.The instrument was removed with the trocar.A piece of the instrument fell in the field but was retrieved.Procedure was completed with no patient harm.Intuitive surgical inc.(isi) follow up with the customer and confirmed fragments were retrieved from the patient.Customer visually inspected and confirmed since it was a single fragment that came off.No additional surgery was required to remove the fragment.An x-ray was conducted to confirm fragments were all retrieved.The instrument was inspected prior to the start of the procedure.The surgeon was attempting to excise tissue when the instrument got stuck.There were no instrument collisions.There was no harm to the patient and no tissue damage.No other information was available.

• 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: 13832826
• MDR Text Key: 292520027
• Report Number: 2955842-2022-10678
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N10210412
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: N10210412 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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