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 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the harmonic ace instrument involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.No image or video was available for review.A review of the instrument logs for the harmonic ace associated with this event could not be performed as the instrument batch sequence number is not available at the time of the event.An event verification confirmed the procedure was performed on the reported event date 24-june-2022 on system sk3594.This complaint is considered a reportable malfunction and adverse event due to the following conclusion: 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 fragment was 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 thyroidectomy surgical procedure, the harmonic ace instrument was found to have the white part at the tip melted and the fragments fell into the patient.The procedure was completed with no report of patient injury.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.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on (b)(6) 2022: the harmonic ace instrument was inspected prior to use and no damage was observed.The teflon pad melted as soon as the customer started to use the instrument.The powder fell into the patient and could not be retrieved.No additional surgical procedure was required to remove the fragment.The harmonic ace 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 the cannula had no other damage after the event occurred.Post-operative tests were not performed to check for remaining fragments.There was no patient injury and the patient did not not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.No bio-debris was found on the harmonic ace instrument jaws.The thyroid tissue did not appear to be too thick.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint.Visual inspection of the harmonic ace instrument found no physical damage to the clamp arm teflon pad.There were no signs of thermal damage and no pieces were missing.The curved blade was inspected, no damage was observed.The harmonic ace instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively, the grips opened and closed properly.The instrument was fully functional.There was no problem detected.A review of the instrument log for the harmonic ace instrument (part number 480275-08/ lot number l90220222 0089) associated with this event has been performed.Per this review of the logs, the harmonic ace instrument was last used in a procedure on (b)(6) 2022 via system serial# (b)(6).This is a single-use instrument.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 15132039
• MDR Text Key: 296895347
• Report Number: 2955842-2022-13241
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)240229(10)L90220222
• 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: 06/30/2022

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: L90220222 0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian