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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC NONE HARMONIC ACE Back to Search Results
Model Number 480275-08
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
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 instrument was found to have a broken blade. The blade broke at roughly 0. 24¿ from the base. 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. The root cause of the ¿broken instrument blades¿ is typically attributed to instrument mishandling and misuse. 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 video was provided. A review of the instrument log for the harmonic ace instrument lot# m90200720 / sequence 0036 associated with this event has been performed. Per logs, the instrument was last used on the reported event date of (b)(6) 2021 on system sk4112. The instrument has 0 remaining usable life, no subsequent use recorded. 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, and the customer had reported that no fragment fell inside 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the ethicon generator had an alarm message indicating to replace the harmonic ace instrument. The customer replaced the harmonic ace instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.
 
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Brand NameNONE
Type of DeviceHARMONIC 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 Key13626474
MDR Text Key290189691
Report Number2955842-2022-10413
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143132
Number of Events Reported1
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 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/03/2021
Device Model Number480275-08
Device Catalogue Number480275
Device Lot NumberM90200720 0036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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