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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI XI; HARMONIC ACE Back to Search Results
Model Number 480275
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
The harmonic ace curved shears instrument has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A follow-up mdr will be submitted 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.No image or video was provided by the site for review.The instrument's lot number was not provided so no log review to confirm event information could be performed.This complaint is being reported based on the following conclusion: it was reported that during a da vinci-assisted surgery, a fragment broke off the instrument and the location of the fragment is unknown.Unintended fragment(s) falling into the patient may require surgical intervention.There was no report of injury resulting from the patient retaining a foreign object, however unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the instrument breakage to occur and the location of he broken instrument piece.
 
Event Description
Medwatch (b)(4) was received with the following information reported from the hospital site: "during intraop robotic hysterectomy, surgeon was using a harnonic ace curved shears (lot 4 m91200415, exp date 04/30/22, ref 480275) and one of the tip prongs was broken while in use.A search for the broken part was done inside the patient and outside, but was not found, surgical manager was informed and communicated with doctor that no xray needed, as per policy.However, he has to disclose the incident to the patient to which he agreed.Intuitive was called.As per operative note: when the dissection of the vaginal cuff was performed, a small piece of the ace harmonic device was broken (distal active blade).We suspect went out to the vaginal cuff, hut we were not able to identify it.At this time, the pelvic cavity was irrigated copiously with warn saline.No active bleeding was identified.The vaginal cuff was closed in a running fashion with 0 vinc without complications.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 09-aug-2021.The reporter noted that the patient was (b)(6), rather than the previously noted 50 years of age.The instrument was inspected prior to use and there was no instrument collision reported.The instrument has not been returned to isi but is available for return.The patient has not returned to the hospital due to any post-surgical complications related to retaining a foreign object.No images or procedure video are available for review.The cause of the breakage and the location of the broken instrument piece remain unknown.
 
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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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12317064
MDR Text Key266388344
Report Number2955842-2021-10928
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number480275
Device Catalogue Number480275
Device Lot NumberM91200415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/14/2021
Initial Date FDA Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
Patient Age49 YR
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