MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI HARMONIC ACE

Model Number 480275-08

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has requested the harmonic ace instrument for evaluation, but the instrument has not yet been received as of the date of this report. 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 for analysis and/or if additional information is received. An instrument log search with the information provided resulted in no additional information. Furthermore, since the instrument batch sequence number was not provided, an instrument log review of the product related to the complaint cannot be performed at this time. In addition, a review of the site's complaint history identified no other complaints related to the harmonic ace instrument. An image of the harmonic ace instrument related to this event was received. A review of the submitted image was performed, and it was confirmed that the blade of the harmonic ace instrument was detached. This complaint is being reported due to the following conclusion: during a da vinci-assisted radical hysterectomy surgical procedure, it was alleged that the blade of the harmonic ace instrument broke off and fell inside the patient. The fragment was retrieved and no additional surgical intervention was required. However, unintended fragments falling inside the patient may require surgical intervention. At this time, it is unknown what caused the breakage to occur. Although there was no patient harm reported, if the alleged malfunction were to recur it could cause or contribute to an adverse event. Blank mdr fields: follow-up was attempted, but the information for the patient-related fields in sections a and b was either unknown, unavailable, or not provided. The expiration date is not applicable. Field is blank because the product is not implantable.

Event Description

It was reported that during a da vinci-assisted radical hysterectomy surgical procedure, the customer discovered the harmonic ace instrument was fractured. There was no report of any fragments falling inside the patient. The customer replaced the harmonic ace instrument with a back-up instrument of the same kind and completed the procedure with no reported injury. On 05-dec-2021, intuitive surgical, inc. (isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use. No instrument collision was observed during the procedure. There was an alarm indicating to relieve the instrument pressure. The instrument blade broke off and fell inside the patient after the customer cleaned and reinserted the instrument. The fragment was retrieved during the same procedure. The instrument is available for return to isi for evaluation. A video recording of the procedure is not available, but an image of the instrument damage was provided. On 23-dec-2021, isi performed follow-up and obtained the following additional information regarding the reported event: the instrument was in use for approximately 90 minutes up until the reported event. The instrument had a recognition issue during the procedure. It was confirmed that there was an alarm indicating to reduce the tool head pressure, and the instrument was fractured. The surgeon thinks there was no instrument collision. After the instrument blade broke off and fell inside the patient, the fragment was visually located and retrieved with laparoscopic instruments. It was confirmed that all fragments were retrieved. No additional surgical procedure was required, and there were no post-operative tests performed to check for remaining fragments. There was no resistance upon final removal of the instrument through the cannula. The surgical staff did not notice any other damage to the instrument or cannula after the event occurred. The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object. It was confirmed there was no patient harm, injury or adverse outcome.

• Brand Name: DAVINCI XI
• 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: 13115177
• MDR Text Key: 291294388
• Report Number: 2955842-2021-11831
• Device Sequence Number: 1
• Product Code: NAY
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 480275-08
• Device Catalogue Number: 480275
• Device Lot Number: L90210622 0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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 Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES