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

Model Number 480275-08

Device Problems Break (1069); Defective Device (2588)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted distal pancreatectomy procedure, the user observed physical damage on the harmonic ace instrument.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instruments that were used intraoperatively were successfully removed and no further information can be provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigation identified a broken curved blade measuring approximately 0.44" x 0.10" in size.The broken piece was not returned with the instrument.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.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.A review of the instrument log for the harmonic ace instrument lot# m90210207 / sequence 0199 associated with this event has been performed.Per logs, the instrument was last used for a procedure on 26-sep-2021 using system sk3193.The reported event indicated an instrument usage on 17-dec-2021.The instrument is single use and should've not been reused for a subsequent procedure.This complaint is considered a reportable malfunction due to the following conclusion: failure analysis investigations found a missing piece from the distal end of the instrument.The missing piece could fall inside the patient during the surgical procedure.While there was no reported harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling inside the patient may require surgical intervention.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.Device expiration date for section d4 was set to 26-sep-2021 based on the usage log of the single use instrument.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.

• 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: 14139066
• MDR Text Key: 298898686
• Report Number: 2955842-2022-11130
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874112738
• UDI-Public: (01)10886874112738(17)230228(10)M90210207
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: 480275-08
• Device Catalogue Number: 480275
• Device Lot Number: M90210207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Date Manufacturer Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES