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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 380652-46
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
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. The reported complaint was not confirmed based on the field evaluation. The fse showed no issues with insertion of the instrument using test equipment. The fse was unable to reproduce the issue on the arm. The customer was asked to drape the robot and it was noted that the drape got caught on the insertion axis and a small tear appeared in the drape. It was confirmed that the drape that was previously used also had a tear at the same location. The fse then supplied proper draping process to avoid tearing. The system was tested and verified as ready for use. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. This event is being reported as a malfunction because a usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure. 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 a procedure change.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the clinical sales representative (csr) reported that arm 3 felt sticky to the customer when installing instruments onto the system. The csr was unable to provide what instrument was sticking. The csr stated the procedure was completed robotically but was unable to provide further details. The technical service engineer (tse) informed that the site could check for drapes causing resistance, use gage pins to ensure the cannulas are round, and check that the instrument sheaths are properly installed on the instruments. The csr requested a field service engineer (fse) to follow up. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) performed follow-up with the customer and obtained additional information. The customer was able to clarify and state that they continued with the procedure without the use of arm 3 in a three arm setup at the time of the issue. The customer also indicated that they were installing the sterile adapter properly.
 
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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 Key13656671
MDR Text Key296700835
Report Number2955842-2022-10438
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-46
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
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: 03/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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