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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED

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INTUITIVE SURGICAL, INC DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED Back to Search Results
Model Number 380723-11
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. Fse replaced the master tool manipulator (mtm) because the opto button fell off. The system was tested and verified as ready for use. The product has been received, but analysis has not been completed. A follow-up mdr will be submitted if additional information is received. A review of the site's complaint history does not reveal any additional complaints involving this product or this event. Intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted error 23031: master tool manipulator (mtm) outputs are saturated, button sensor #3 on mtml. This complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient¿s inability to tolerate a conversion. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the finger clutch button on one of the master tool manipulators (mtm) fell off. The surgeon moved to another surgeon side console (ssc) and continued with the procedure. Intuitive surgical, inc. (isi) technical support engineer (tse) reviewed the logs and noted error 23031: mtm outputs are saturated, button sensor #3 on mtml. Isi followed up with the initial reporter (nurse) and confirmed that the procedure was completed robotically using the second surgeon side console (ssc) with no injury to the patient.
 
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Brand NameDA VINCI XI
Type of DeviceSURGEON SIDE CONSOLE, RECONDITIONED
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 Key13146214
MDR Text Key289758131
Report Number2955842-2022-10002
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 Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380723-11
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2021
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 Treatment Data
Date Received: 01/03/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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