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

Model Number 480275-08

Device Problem Material Fragmentation (1261)

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

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the harmonic ace was found to have the instrument tip broken and it fell into the patient with no excessive use.The fragment was retrieved from the abdominal cavity during the same procedure.A backup instrument of the same kind was used to continue the procedure.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed.The instrument was in use for about 30 minutes and broke while it was being used for dissecting tissue.All the fragments were retrieved during the same procedure and confirmed with visual inspection.No additional surgical procedure was required to remove the fragment.It was unknown what caused the breakage to occur as the instrument did not collide with any hard materials or other instruments.There was no patient injury.The surgeon did not notice any issues with the functionality of the instrument.The fragment(s) did not fall inside the patient during an instrument tip or accessory collision.The instrument was not removed during the procedure (prior to the breakage).Upon final removal of the instrument, the wrist was straightened, and the surgical staff did not feel any resistance upon removal of the instrument through the cannula.Both instrument and cannula had no other damage after the event occurred.No post-operative tests like an x-ray or ultrasound were performed to check for remaining fragments.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the harmonic ace instrument for evaluation.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.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.In addition, a review of the instrument log for the harmonic ace (part # 480275-08/lot# l90211108 0127) associated with this event has been performed.Per logs, the instrument was used on (b)(6) 2022, on system (b)(4).This is a single-use instrument.No image or video clip for the reported event was submitted to isi for review.This event is being reported because the tip of the harmonic ace instrument reportedly broke and fell inside the patient during a da vinci assisted procedure.The fragment was retrieved during the same procedure with no patient injury.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 are not available fields are not applicable.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint ¿the harmonic ace was found to have the instrument tip broken¿.Failure analysis found the primary failure of broken blade to be related to the customer reported complaint.For clarification, the harmonic insert curved blade was found to be broken near the blade base.The blade broke roughly at 0.123¿ from the base.The broken piece was returned, no pieces are missing.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 of broken instrument blades is typically attributed to user mishandling/misuse.A review of the instrument log for the harmonic ace (part # 480275-08/lot# l90211031-0112) associated with this event has been performed.Per logs, the instrument was used on 24-mar-2022, on system (b)(4).This is a single-use instrument.A review of the procedure log showed the site performed this distal gastrectomy surgical procedure on 24-mar-2022 with system (b)(4).Refer to appropriate fields within the complaint.

• 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: 14191102
• MDR Text Key: 294641884
• Report Number: 2955842-2022-11224
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)231031(10)L90211031
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• 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: L90211031 0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Asian