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

Model Number 400272-03

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the harmonic ace insert for evaluation, but the device 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.The device information cannot be verified through the system log review as there are no logs available for si harmonic ace inserts.In addition, a review of the site's complaint history identified no other complaints related to the harmonic ace insert.An image of the harmonic ace insert related to this event was received and reviewed.The image confirmed that the harmonic ace insert blade was missing/detached.This complaint is being reported due to the following conclusion: during a da vinci-assisted pancreaticoduodenectomy surgical procedure, it was alleged that the blade of the harmonic ace insert broke off and fell inside the patient.The fragment was retrieved during the same procedure.At this time, it is unknown what caused the breakage to occur.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.Field is blank because insufficient product information was provided in order to obtain the date of manufacture.

Event Description

It was reported that during a da vinci-assisted pancreaticoduodenectomy surgical procedure, the blade of the harmonic ace insert broke off and fell inside the patient.The fragment was retrieved during the same procedure.The customer replaced the harmonic ace insert with a back-up device of the same kind and completed the procedure with no reported injury.On (b)(6) 2022, intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the device was reportedly inspected prior to use, and no issues were noted.The device was in use for one minute and performed as intended up until it broke.The surgeon was dissecting tissue at the time of the event.No instrument collision was observed during the procedure.After the blade broke off and fell inside the patient, the fragment was retrieved during the same procedure.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.The surgical staff did not remove the device prior to the breakage.The surgical staff did not feel any resistance upon final removal of the device through the cannula.The surgical staff did not notice any other damage to the device or cannula after the event occurred.The device is available for return to isi for evaluation.There is no video recording of the procedure, but an image of the device damage was provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace insert involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found that the harmonic ace insert was had a broken blade.The blade broke at roughly 0.074¿ from the base and the broken piece was not returned.Cracked or broken blades 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 may be detected by the generator with a solid tone or an error.The root cause was typically attributed to mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem" b2 updated to "required intervention" h1 updated from "malfunction" to "serious injury".

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: 14169016
• MDR Text Key: 289766815
• Report Number: 2955842-2022-11175
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112584
• 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,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400272-03
• Device Catalogue Number: 400272
• Device Lot Number: L90210618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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