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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 380652-37
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the customer observed universal surgical manipulator (usm) 4 would not advance instruments. The customer stated this issue occurred with scissors on usm4. Prior to calling, the customer removed usm4 and proceeded with usms 1, 2 and 3. The technical service engineer (tse) reviewed the logs and found no errors. The tse inquired if another non-cautery instrument had been used on usm4, in case the tip cover was related, and the customer was unsure. The tse asked if the sterile adapter had been reseated and the customer was unsure. The customer proceeded with the case. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the robotic coordinator (roco) and obtained the following additional information: the roco informed that the arm was successfully used during the case prior to the issue. The issue occurred about 30 minutes into the procedure. System functionality was checked upon power up and the system powered on without issue. The surgery was completed robotically. The suspect arm was not used after the issue occurred for the remainder of the procedure. No non-intuitive motion was observed and there were no external interference. Patient demographic information was requested but not provided.
 
Manufacturer Narrative
An intuitive surgical, inc. (isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The fse tested the universal surgical manipulator (usm) through friction tests and all tests passed without issues. The fse replaced usm4 for customer satisfaction as the customer reported of intermittent resistance on insertion with and without a drape over arm. The system was tested and verified as ready for use. Isi received the usm involved with this complaint. The failure analysis investigation has not been completed yet. A follow-up mdr will be submitted if additional information is received upon completion of the component evaluation. A review of the site's complaint history does not reveal any related complaints involving this product and/or this event. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. No image or procedure video was provided for review. This complaint is considered a reportable event due to the following conclusion: an 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 conversion/abortion.
 
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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 Key13894209
MDR Text Key297367616
Report Number2955842-2022-10759
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,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380652-37
Device Catalogue Number380652
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
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: 03/24/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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