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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM Back to Search Results
Model Number 381121-29
Device Problems Visual Prompts will not Clear (2281); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted hysterectomy-malignant surgical procedure, monopolar and bipolar energy were not working.The customer attempted to replace energy cables, and instruments with no success.The customer used a third-party generator (force triad) and continued with the procedure.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and noted u-04 error on the integrated electro surgical unit (iesu).Tse informed the customer to reboot the iesu.Isi followed up with the initial reporter (nurse) and obtained additional information: the procedure was completed robotically using the third-party generator with no injury to the patient.
 
Manufacturer Narrative
Intuitive surgical, inc.(isi) field service engineer (fse) followed up with the customer on the phone.The customer power cycled the system and the integrated electro surgical unit (iesu) to clear the errors.The system and iesu powered back on without any errors.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's system logs for the reported procedure date was conducted by intuitive surgical, inc.(isi) technical support engineer (tse).Investigation revealed the following possible related system errors: u-02 on the integrated electro surgical unit (iesu).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: the customer elected to use the third-party generator after the start of the procedure due to errors on the integrated electro surgical unit (iesu).While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.
 
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Brand Name
DAVINCI XI
Type of Device
VISION SIDE SYSTEM
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 Key14069069
MDR Text Key298805947
Report Number2955842-2022-10991
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110898
UDI-Public(01)00886874110898
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 Other,Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381121-29
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received04/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
Patient SexFemale
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