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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

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INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380652-48
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  malfunction  
Manufacturer Narrative
An intuitive field service engineer (fse) followed up with the customer following the reported event. The customer stated that arm 3 was exercised after the procedure and no issues were found. The customer stated that the issue was likely due to the arms being too close together and not in a suitable position. No site visit was conducted by the fse. The system was working properly, and no additional action was required. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No images or procedure videos were provided for review. This complaint is reportable due to the following: a universal surgical manipulator (usm) was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms. 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. System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.
 
Event Description
It was reported that during a da vinci-assisted oophorectomy surgical procedure that there was resistance when inserting instruments in arm 3. Prior to calling technical support, the customer undocked arm 3, checked the drape, and also switched out the instrument. The intuitive tech support engineer (tse) recommended they change out the drape and/or trocar. The surgeon elected to dock arm 4 and move the instrument to arm 4. After the arm swap the customer was able to continue. The tse recommended after the case that the customer check the insertion axis on arm 3 without the drape and see if they still felt the resistance. The tse found no related errors in the logs. There were no report of patient injury. Intuitive surgical inc (isi) had made a follow-up attempt to obtain additional information. However, no further details have been received as of the date of this report.
 
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Brand NameDAVINCI XI
Type of DevicePATIENT SIDE CART, 4-ARM
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 Key14069308
MDR Text Key298580661
Report Number2955842-2022-11001
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110720
UDI-Public(01)00886874110720
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
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-48
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2020
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: 04/10/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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