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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS4000 A70P7B
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the illuminator involved with this complaint and completed investigation. Failure analysis investigation confirmed the reported failure. The main board was found defective.
 
Manufacturer Narrative
Additional information can be found in the following sections: type of report, if follow-up what type, and additional narrative. Intuitive surgical, inc. (isi) received the high resolution stereo viewer (hrsv) monitor involved with this complaint and not an illuminator. Please see corrected failure analysis below. Intuitive surgical, inc. (isi) has received the hrsv monitor involved with this complaint and completed investigation. Failure analysis investigation confirmed the reported failure. The main board was found defective.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the unit involved with this complaint for failure analysis evaluation, however, the evaluation is still in progress. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted once the evaluation has been completed and/ or if additional information is received. This complaint is being reported 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. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, there was no image in the left eye of the high resolution stereo viewer (hrsv). Due to the issue, the procedure was converted and completed using traditional laparoscopic techniques. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the issue was noticed at the beginning of the procedure when the surgeon went to sit at the console. The customer called the field service engineer (fse) for troubleshooting assistance. The customer performed a power cycle of the entire system several times. At that time, the surgeon converted to laparoscopy as he did not have 3d at the console. There was no harm to the patient. An isi fse was dispatched to the facility and was able to reproduce the reported failure. To resolve the issue the fse replaced the hrsv. The hrsv is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.
 
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Brand NameDA VINCI XI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
MDR Report Key7154838
MDR Text Key250278441
Report Number2955842-2017-00882
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 distributor,foreign
Type of Report Initial,Followup,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P7B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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