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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DA VINCI XI SURGICAL SYSTEM PATIENT SIDE CART, 4-ARM Back to Search Results
Model Number 372192-10
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2018
Event Type  malfunction  
Manufacturer Narrative
The spm has not been returned for evaluation. Therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the spm is returned (post failure analysis evaluation) or if additional information is received. Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2018. The system logs reveal that numerous system errors were generated between the start and end of the surgical procedure which lasted approximately 30 minutes based on the information provided at this time, this complaint is being classified as a reportable event due to a da vinci system malfunction 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 cause or contribute to an adverse event.
 
Event Description
It was initially reported that prior to the start of a da vinci-assisted surgical procedure, the patient side cart (psc) would not start up. During the event, the site contacted an intuitive surgical, inc. (isi) technical support engineer (tse) for assistance. The issue was resolved temporarily after the site replaced the blue fiber cable on the psc. At an unspecified time later, the site called the tse back and indicated that the system randomly turned off. The tse advised the site to continue the planned surgical procedure using a single console instead of dual console. On 16-mar-2018, the isi clinical sales representative (csr) provided the following information regarding the reported event: prior to starting the da vinci-assisted surgical procedure, the site encountered an unrecoverable error. A tse was called for troubleshooting. After a successful restart, the surgical staff prepared the patient, placed the trocars and docked the psc to the trocars. At that moment, the unrecoverable fault showed up again. Again, the tse was contacted and an isi clinical sales representative (csr) went to the site to help with troubleshooting. After several attempts to troubleshoot the alleged issue failed, the csr indicated that the site recognized that they could not make the system work and the surgeon decided to abort the operation. The trocars were removed and incision ports were closed. In total the patient was under anesthesia for approximately three hours. On 19-mar-2018, an isi field service engineer (fse) performed a field evaluation at the site. The fse replaced the system power manager (spm) assembly to resolve the customer reported issue. The fse then tested the system and verified that it was ready for use.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the system power manager (spm) involved with this complaint and completed investigations. The unit was returned for failure analysis but the reported failure could not be replicated. The spm was installed in the test system and it came up with no errors and the patient side cart (psc) functioned normal with no issues. After the unit was upgraded, a system test was performed and the customer reported issue of ¿psc won¿t start up¿ was replicated. The intermittent issue was caused by a system power management power board (spmp). The spmp was replaced and the unit passed all tests. Based on the current information provided, this complaint will remain reportable due to a da vinci system malfunction 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 cause or contribute to an adverse event.
 
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Brand NameDA VINCI XI SURGICAL SYSTEM
Type of DevicePATIENT SIDE CART, 4-ARM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
MDR Report Key7374057
MDR Text Key103935415
Report Number2955842-2018-10105
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number372192-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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