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

Model Number 480275-08

Device Problem Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/14/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted distal gastrectomy procedure, about an hour into the operation, the ethicon generator of the harmonic ace instrument was reporting that the pressure of the knife head was too large.During the operation, the patient suffered from a lot of bleeding.The nurse pulled out the harmonic ace instrument for re-testing, and the ethicon generator suggested that the instrument should be replaced.Intuitive surgical, inc.(isi) followed up with the nurse and obtained the following information: the event occurred during the first procedure of the day.The instrument issue was resolved by using a backup harmonic ace instrument.The procedure was completed robotically.Isi followed up with the first assistant and obtained the following information: there was unexpected bleeding that occurred from "small blood vessels from the cardia and pylorus." the site stated that the coagulation effect of the ultrasonic knife was "not very good" and that the da vinci product caused and contributed to the bleeding.The surgeon used hem-o-lock clips and hemostatic drugs to stop the bleeding.The amount of blood loss was 300 ml.

Manufacturer Narrative

Based on the current information provided, the cause of the customer reported failure mode and intra-operative complication cannot be determined.Isi has requested for return of the harmonic ace instrument for failure analysis evaluation.However, isi has not received the harmonic ace instrument involved with this complaint.Therefore, the causes of the alleged customer reported failure mode and intra-operative complication cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the system logs verified that a da vinci-assisted distal gastrectomy procedure was carried out on system sk 2922 on 14-feb-2022.The lot number l90210622 provided by the customer could not be verified based on a review of the instrument logs.The error logs for the procedure date 14-feb-2022 were reviewed and there were no observed events that would suggest a product issue, and logged events are in line with normal system functionality.Images sent by the customer were reviewed by the isi clinical development engineering (cde) team and the following information was obtained: the pad appears to be intact, but the blade has some scratches/indentations which are visible in the second image.The pressure error may show up for a damaged blade.The case was reviewed by an intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and the following findings were obtained: the error "pressure of the knife head was too large" is a common error seen and indicates that the ethicon generator detected that the instrument has been loaded to a point where the output has been stopped.When this occurs, the activation of the instrument will be stopped and the user needs to relax the pressure on the instrument or reposition the harmonic ace instrument so that there is less tissue within the jaws of the instrument.This error message is typically due to a use error, caused by grabbing too much tissue, grasping hard objects, collision of the instruments or cracks/scratches and indentations in the blade.Users are required per ifu to self-test the harmonic ace instrument prior to use.If there was any manufacturing deficiency that prevents activation of the blade, it will be detected during the self-test.If the instrument is not damaged, the error is usually resolved by releasing and re-grasping tissue.This complaint is being reported due to the following conclusion: during a da vinci-assisted gastrectomy procedure, the ethicon generator of the harmonic ace instrument reported that the pressure of the knife head was too large.There was bleeding from the small blood vessels of the cardia and pylorus which required the usage of hem-o-lock clips and hemostatic drugs.The surgeon stated that the bleeding was unexpected and that the coagulation effect of the harmonic ace instrument was ¿not very good.¿ although there were indentations/scratches on the blade of the instrument which may have produced the pressure error message, the causes of the customer reported failure mode and intra-operative complication are unknown.

Manufacturer Narrative

D11: intuitive surgical, inc.(isi) has received the harmonic ace curved shears instrument associated with this complaint and completed investigations.The surface of the curved blade was found to be damaged with scratch/abrasive marks.Damages to the blade are triggered by any inadvertent contact with staples, clips, or other instruments while the device is activated.In addition, scratches on the blade tip may also lead to premature blade failure.Blade damage was detected by the generator with a solid tone or an error.Root cause is attributed to the user.

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: 13830786
• MDR Text Key: 292514954
• Report Number: 2955842-2022-10668
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)230630(10)L90210622
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

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: L90210622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• 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.