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

Model Number 480275-08

Device Problem Insufficient Information (3190)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The harmonic ace instrument has been requested to be returned for failure analysis investigation.However, as of the date of this report, the instrument has not yet been received.Review of the provided image showed that a piece of the instrument blade appeared to be missing.The issue cannot be confirmed without the instrument being returned and evaluated.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the harmonic ace was not working.The user completed the procedure using a backup harmonic ace with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information about the event.The instrument was inspected prior to use and there was no damage observed.There was no instrument collision and no fragment fall into the patient.There was no injury to the patient.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The harmonic ace instrument was analyzed and found to have a broken curved blade.The broken piece measured approximately 0.42" x 0.10" and was returned.No material appeared to be missing as the broken assembly was pieced back together.The complaint was confirmed by failure analysis.

• 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: 18433185
• MDR Text Key: 331827255
• Report Number: 2955842-2024-10008
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)250228(10)L83230210
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275-08
• Device Catalogue Number: 480275
• Device Lot Number: L83230210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES