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

Model Number 480275-08

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the harmonic ace curved shears for failure analysis investigation.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.Based on the information provided at this time, this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment broke off and fell inside the patient.All fragments were retrieved and no additional surgical intervention was required.However, at this time, it is unknown what caused the breakage to occur.

Event Description

During a da vinci-assisted liver resection surgical procedure, it was reported that the system generated an alarm to indicate excessive stress on the harmonic ace curved shears three times.Following this, the instrument broke inside the patient.The fragment was retrieved during the same procedure.The procedure was completed with a backup da vinci instrument of a different kind.There was no reported patient harm or injury.Due to the reported issue, there was a surgical procedure delay of 10 minutes.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the unit was inspected prior to use, and there was no damage.The breakage occurred after 90 minutes of use.The blade of the harmonic ace broke during self-test, and this was confirmed from the procedure video, but the surgeon did not do anything.No functionality issues were noted during use.The surgeon was dissecting tissue when the fragment broke.There was no report of instrument collision and the instrument was not removed during the procedure.The fragment was retrieved through the assistant port.Upon final removal of the instrument, the surgical staff did not see any damage to the cannula, to the reported instrument, or to the other instruments.No post-operative tests or procedures were performed.The patient did not have any post-surgical complications.

Manufacturer Narrative

Additional information can be found in the following sections: d4, d10, g4, g7, h2, h3, h6 and h10.61 - intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.The reported failure was confirmed during failure analysis.The instrument was found with a broken curved blade.The broken piece, approximately 0.61" x 0.10" was returned.No material was missing as the broken assembly was pieced back together.Any inadvertent contact with staples, clips, or other instruments while the device is activated may result in a cracked or broken blade.Blade damage may be detected by the generator with a solid tone or an error.Scratches on the blade tip may also lead to premature blade failure.The root cause of this failure is fatigue failure due to mishandling/misuse.Based on the failure analysis results, the initial mdr report is being retracted as the damage to the instrument was found to be due to mishandling/misuse and not due to a malfunction of the unit.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: HARMONIC ACE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9528143
• MDR Text Key: 196256936
• Report Number: 2955842-2019-11005
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)210131(10)M10190211
• Combination Product (y/n): N
• PMA/PMN Number: K143132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275-08
• Device Lot Number: M10190211 0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES