MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; HARMONIC ACE

Model Number 480275-08

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the harmonic ace instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/ or if additional information is received.An instrument log search with the information provided resulted in no additional information.Furthermore, since the instrument batch sequence number was not provided, an instrument log review of the product related to the complaint cannot be performed at this time.In addition, a review of the site's complaint history identified no other complaints related to the harmonic ace instrument.No image or video clip for the reported event was submitted to isi for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted mediastinal surgical procedure, it was alleged that the "tine" of the harmonic ace instrument broke off and fell inside the patient.The fragment was retrieved and no additional surgical intervention was required.However, unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event.Follow-up was attempted, but the information for the patient-related fields in sections a and b was either unknown, unavailable, or not provided.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted mediastinal surgical procedure, the customer reported that the "tines" of the harmonic ace instrument broke off.The customer also reported that there was no "illegal operation" during the procedure.There was no report of any fragments falling inside the patient.The customer replaced the harmonic ace instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.On 29-nov-2021, intuitive surgical, inc.(isi) performed follow-up with the customer and obtained the following additional information regarding the reported event: the "tine" of the harmonic ace instrument broke off and fell inside the patient's abdomen.The fragment was retrieved during the same procedure.The harmonic ace instrument did not collide with any other instrument during the procedure.The harmonic ace instrument was reportedly sent back to isi for evaluation.On 16-dec-2021, isi performed follow-up with the customer and obtained the following additional information regarding the reported event: it is unknown if the harmonic ace instrument was inspected prior to use.The harmonic ace instrument performed as intended up until the reported event.It was confirmed that the fragment was retrieved during the same procedure.The customer also confirmed all fragments were retrieved from a video review.The site conducted an x-ray and found no foreign body inside the patient.No additional surgical procedure was required, and there was no harm to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The harmonic ace instrument was removed prior to the breakage with resistance through the cannula, but the surgical staff didn¿t think there was anything unusual.Upon final removal of the harmonic ace instrument, there was no resistance through the cannula.The surgical staff did not notice any other damage to the harmonic ace instrument or cannula after the event occurred.It is unknown if there are any photographic images of the harmonic ace instrument.The customer could not provide a video recording of the procedure.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, and h3.Corrected information is found in the following fields based on the product that was returned for investigation: d4 (product lot number), d4 (unique identifier), h4 (device manufacture date), and b3 (event date).Product evaluation information can be found in the following fields: h6 and h10.D11 - intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary finding of the broken blade to be related to the customer reported complaint.The blade broke at roughly 0.160¿ from the base.The broken piece was not returned with the instrument.Cracked or broken blades are triggered by any inadvertent contact with staples, clips, or other instruments while the device is activated.In addition, scratches on the blade tip may also lead to premature blade failure.Blade damage may be detected by the generator with a solid tone or an error.The root cause of the broken instrument blades is typically attributed to mishandling/misuse.There was an additional observation not reported by the site and not related to the reported issue.The instrument was found to have a broken clamp arm.The clamp arm was not properly attached to the instrument.The root cause of this failure is also attributed to mishandling/misuse.A review of the logs showed the harmonic ace instrument (part# 480275-08 / lot# m90201201-0037) was last used on 28-may-2021 during a procedure with system sk3193.The harmonic ace instrument is a single-use device.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem" b2 updated to "required intervention" h1 updated from "malfunction" to "serious injury".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: HARMONIC ACE
• 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: 13082860
• MDR Text Key: 284704740
• Report Number: 2955842-2021-11806
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)221130(10)M90201130
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275-08
• Device Catalogue Number: 480275
• Device Lot Number: M90201201 0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Race: Asian