MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 CURVED-TIP

Model Number 480545-04

Device Problems Unintended System Motion (1430); Material Separation (1562); Output Problem (3005)

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

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting that the sureform 45 curved-tip stapler had a recognition issue, moved in an unintended way, and the staple fell into the patient¿s anatomy, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.The investigation to determine the cause of this reported event is currently in progress.A review of the provided video was performed by an intuitive surgical, inc.(isi) clinical development engineer (cde).The following additional information was provided: it was confirmed that the stapler moved suddenly to the left while grasping tissue.The surgeon¿s foot was over the pedals at the time, but had not clamped the stapler yet.Without viewing the hand controls, the root cause of the issue could not be determined.There were also some loose staples seen after the stapler fired and they were removed from the tissue.This complaint is considered a reportable event due to the following conclusion: it was alleged that the sureform 45 curved-tip stapler instrument moved with unintuitive motion (e.G.The instrument moved in an unexpected/unintended way).Unintuitive motion could lead to subsequent tissue damage.In addition, a staple fell inside the patient as a result of the movement, during a da vinci assisted procedure.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer reported that the sureform 45 curved-tip stapler had a recognition issue.The procedure was completed with no reported injury with a backup sureform 45 curved-tip stapler.The following additional information was obtained from a procedure video review: the sureform 45 curved-tip stapler swayed to the side with no command and the staple fell into the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the physician and obtained the following additional information: the sureform 45 stapler was inspected prior to use with no issue.Engagement failure occurred during the procedure.There was no tissue damage due to stapler's non-intuitive motion.Not all staples were retrieved.No additional surgical procedure was required to remove the staples.Post-operative tests (x-ray and ultrasound) were performed.The patient has not returned to the hospital for any post-surgical complications related to retaining a foreign object.There was no patient injury.Intuitive surgical, inc.(isi) received the sureform 45 curved-tip stapler involved with this complaint and completed the device evaluation.Failure analysis confirmed but did not replicate the reported complaint.The instrument was found to have 14 engagement failures based on log review.This failure was not replicated during in-house testing.Log review shows error code 22020 indicating engagement failure of the sureform 45 curved-tip stapler.The instrument was installed onto the system with an in-house drape and seal.The instrument passed the recognition and engagement tests on all three attempts.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.There was no physical damage found.The root cause of this failure was not determined.An additional observation, which was related to the customer-reported complaint was identified.The instrument was found to have roll friction on the main tube when manually rotating the main tube of the stapler compared to an in-house stapler.The binding between the main bushing and roll gear was found to be improper.The probable root cause of the roll friction on the main tube is attributed to manufacturing.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Type of Device: SUREFORM 45 CURVED-TIP
• 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: 16330583
• MDR Text Key: 309126261
• Report Number: 2955842-2023-10586
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)T11220901
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480545-04
• Device Catalogue Number: 480545
• Device Lot Number: T11220901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• 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