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 07/08/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted thyroidectomy surgical procedure, the harmonic ace instrument was found to have the white teflon pad melted and powder was blown out while being used for tissue resection.The fragments fell into the patient¿s cavity and were not retrieved.The procedure was continuing as planned.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument and accessory were inspected prior to use with no damage observed.During the procedure, the teflon pad melted.The powder fell into the patient and could not be retrieved.No additional surgical procedure or post-operative tests like an x-ray or ultrasound were performed.It was unknown what caused the fragment falling issue as 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.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "it was reported that during a da vinci-assisted thyroidectomy surgical procedure, the harmonic ace instrument was found to have the white teflon pad melted." failure analysis found the primary failure of teflon pad damage to be related to the customer reported complaint.Visual inspection was performed, and the instrument was found to have teflon pad damage on the clamp arm.No material appears to be missing.The teflon pad appears to be partially dislodged from the clamp arm.Root cause of this failure is attributed to mishandling/misuse.No image/video investigation required as no image or video clip for the reported event was submitted for review.A review of the instrument log for the harmonic ace instrument (part# 480275-08| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the harmonic ace instrument was last used on (b)(6) 2022 via system serial# (b)(4).This is a single-use instrument.A review of the procedure log showed the site performed this thyroidectomy surgical procedure on (b)(6) 2022 via system serial# (b)(4).This complaint is being reported due to the following conclusion: it was alleged that the harmonic ace instrument had the white teflon pad melted, and powder was blown out.The fragments fell inside the patient during a da vinci assisted procedure and were not retrieved.

• 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: 15636831
• MDR Text Key: 302050492
• Report Number: 2955842-2022-14705
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)240331(10)L90220321
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: L90220321 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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