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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI SI PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 380614-15
Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was reproduced during field evaluation. The fse checked the system in normal mode and found that axis3 could not insert. The fse performed a sine cycle for 5 minutes on the ecm, and the result was normal. The fse restarted the system, the tip occurred on the monitor, but the camera arm was not free to move. The fse reviewed the error log, and error 23007 occurred multiple times pointing to axis3. The fse checked the wheel status; all of them were normal. The fse exchanged remote arm controller (rac) 3 and rac4, but the tip still occurred on the monitor, and the ecm led turned yellow. The fse replaced the ecm, which resolved the issue. The system was tested and verified as ready for use. Isi received the ecm involved with this complaint and completed the device evaluation. The reported complaint was confirmed during failure analysis. The axis 3 brake will be replaced as a fix. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted adrenalectomy surgical procedure, the endoscope could not insert. There were no error messages displayed. The endoscopic camera manipulator (ecm) yaw and pitch movements were fine, but the movement on the insertion axis was stuck. The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer reseat the drape and power cycle the system, but the issue persisted. The tse had the customer to check the endoscope cannula, and the customer reported the cannula was normal, and the endoscope was able to go through it smoothly. The customer confirmed that the endoscope carriage could not move when ecm is unclutched. The procedure was converted to laparoscopic surgery with no reported injury. On 16-april-2021, isi obtained the following additional information from the customer: the system was powered on before port placement. After the system was turned on, the self-check was passed, and there was no errors displayed on the monitor. The fault occurred when the endoscope was installed after the patient had been anesthetized. Patient history, pre-existing medical conditions, and relevant tests and laboratory data were requested; however the customer cannot provide information about patients and surgeries.
 
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Brand NameDAVINCI SI
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key11810977
MDR Text Key268211746
Report Number2955842-2021-10497
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874110690
UDI-Public(01)00886874110690
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380614-15
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2016
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

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