MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HARMONIC ACE

Model Number 480275-08

Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the harmonic ace instrument for evaluation.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 and evaluated and/ or if additional information is received.No images or videos were submitted for review.The batch sequence number of the product's lot number was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.A review of the rfe procedure log showed the site performed this liver resection surgical procedure on (b)(6) 2022 via system serial# (b)(4).This event is being reported because it was alleged that the white part at the harmonic ace instrument tip melted, and the fragments fell inside the patient during a da vinci assisted procedure.The fragments were not retrieved.At this time, it is unknown what caused the event to occur.

Event Description

It was reported that during a da vinci-assisted liver resection surgical procedure, the white part at the tip of the harmonic ace instrument was damaged after a short period of time.The fragment fell from the harmonic ace instrument but was not retrieved.Earlier prior to starting the procedure, the customer already replaced the first harmonic ace instrument due to an error message.The customer then elected to use the vessel sealer instrument and continued the procedure.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed.After the customer used the instrument for less than 5 minutes for dissecting tissue, the teflon pad melted.The powder fell into the patient and could not be retrieved.The customer found the instrument was defective.No additional surgical procedure or post-operative tests like an x-ray or ultrasound were performed.In addition, the instrument did not collide with any hard materials or other instruments.The surgeon did not notice any issues with the functionality of the instrument.The instrument was not removed during the procedure (prior to the breakage).Upon final removal of the instrument, the wrist was straightened, and the surgical staff did not feel any resistance upon removal of the instrument through the cannula.Both instrument and cannula had no other damage after the event occurred.The patient had no injury/harm and has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.Information regarding patient relevant testing, and medical history were requested however, the reporter was not able to provide that information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "the white part at the tip of the harmonic ace instrument was damaged after a short period of time." failure analysis found the primary failure of clamp arm damaged teflon pad to be related to the reported complaint.The instrument was found to have the teflon pad damaged at the distal tip and proximal end.The root cause is typically attributed to mishandling/misuse.An additional observation not reported by site was that the instrument was found to have a broken blade.The blade broke at roughly 0.134¿ from the base.The broken piece was not returned.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 broken instrument blades is typically attributed to mishandling/misuse.A review of the instrument log for the harmonic ace instrument (part# 480275-08| lot/serial# (b)(6) associated with this event has been performed.Per this review of the logs, the harmonic ace instrument was last used on 18-may-2022 via system serial# (b)(6).This is a single-use instrument.A review of the rfe procedure log showed the site performed this liver resection surgical procedure on (b)(6) 2022 via system serial# (b)(6).Additional information can be found in the following fields: d9, g3, g6, h2, and h3 corrected information can be found in the following fields: b3 (event date), d4 (batch sequence and unique identifier), and h4 (device manufacture date) were updated.Failure analysis information can be found in the following fields: h6 and h10.

• Brand Name: NONE
• 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: 15353339
• MDR Text Key: 299260942
• Report Number: 2955842-2022-13833
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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: L90211205 0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian