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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM Back to Search Results
Model Number 380990-08
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2018
Event Type  malfunction  
Manufacturer Narrative
The unit has been returned to isi for failure analysis evaluation. Failure analysis replicated/confirmed the illuminator issue. The unit was installed on an in-house pca system and it failed during power up. System error code # 48238 was generated. Visual inspection found that the unit's fan was very dusty. The unit will be repaired. This complaint is being reported due to a da vinci surgical 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 reported that during a da vinci-assisted hysterectomy procedure, system error code #297 was generated and the illuminator would not turn off. The customer contacted intuitive surgical, inc. (isi) for technical support assistance. The isi technical support engineer (tse) instructed the customer to reseat the lamp module, however, after restarting the system, system error code #297 recurred. The tse then instructed the customer to power down the system, remove the illuminator control cable and restart the system. After restarting the system, error code #48238 was generated. The customer was able to recover the fault, however, the customer made the decision to use a third party illuminator to complete the planned surgical procedure. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the site. The fse was able to reproduce the customer reported complaint the fse investigation concluded that the system error code #297 and system error code #48238 were associated with the illuminator. To resolve the issue, the fse replaced the illuminator. The illuminator provides the light which is transported to the system endoscope and projected onto the surgical site.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7653209
MDR Text Key112871565
Report Number2955842-2018-10340
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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