MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; HARMONIC ACE

Model Number 480275-08

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/21/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations replicated and confirmed the customer reported complaint "teflon pad was melting and fragments were falling down".Failure analysis found the primary failure of teflon pad damage to be related to the customer complaint.Visual inspection of the instrument found the teflon pad exhibited thermal damage near the base of the clamp arm.A piece measuring roughly 0.027" x 0.034" was missing from the teflon pad and was not returned with the instrument.No blade damage was observed.The root cause for the teflon pad damage is attributed to mishandling/misuse.A review of the instrument log for the harmonic ace (part # 480275-08/lot# l902109220086) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021, on system sk3594.This is a single-use instrument.In addition, a review of the site's complaint history identified no other complaints related to the instrument and or this event.No image or video clip for the reported event was submitted to isi for review.Based on the information provided at this time, this complaint is being classified as a reportable adverse event due to the following conclusion: the harmonic ace instrument was found to have the teflon pad melted.The fragments fell inside the patient and were not retrieved.Failure analysis confirmed the issue and the root cause was attributed to user mishandling or misuse.Per fa investigation findings, there is no evidence that a device malfunction caused/contributed to the alleged event.

Event Description

It was reported that during a da vinci-assisted thyroidectomy surgical procedure, the harmonic ace instrument was found to have the teflon pad melted, and fragments were falling inside the patient.The fragments were not retrieved.The customer removed the instrument and used a backup instrument to complete the procedure.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.The teflon pad melted like powder as soon as the customer started to use the instrument.The fragments were not retrieved as they were noted to be "like powder." it was unknown what caused the melting to occur as the instrument did not collide with any hard materials or other instruments, and the customer confirmed that arcing was not observed.The thyroid tissue did not appear to be too thick.The surgeon did not notice any issues with the functionality of the instrument.No post-operative tests like an x-ray or ultrasound were performed, and no additional surgical procedure was performed.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The da vinci 8 mm harmonic ace curved shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue.It is designed to be used in conjunction with a compatible da vinci surgical system and a compatible ethicon endo-surgery generator and hand piece.

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 adverse event, as previously reported.Corrected information can be found the following field: b1, h6 b1 updated from "adverse event" to "adverse event and product problem".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• 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: 13314710
• MDR Text Key: 284182348
• Report Number: 2955842-2022-10106
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)230930(10)L90210922
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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: 480275-08
• Device Catalogue Number: 480275
• Device Lot Number: L90210922 0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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