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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 A70P6B
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 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc (isi) will not be receiving the optic backplane cable fiber and fiber optic cable as both items were scrapped in the field. A follow-up mdr will be submitted if the 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.
 
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer experienced a non-recoverable 319 fault and a message to disable the boom and the cart drive. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to emergency power off the system with a hard power cycle with no change. The customer made the decision to convert and complete the procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury. Isi made a follow up attempt and obtained the following additional information: the isi clinical sales representative (csr) confirmed that the patient was under anesthesia and post incisions and insertions had been completed when the issue occurred. They were ready to drive the patient cart to dock when they received the error message. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure. To resolve the issue, the fse replaced the optic back plane cable fiber and fiber optic cable. The pbp is a board on the patient side cart (psc) to which everything connects to.
 
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Brand NameDA VINCI XI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7049386
MDR Text Key93444868
Report Number2955842-2017-00783
Device Sequence Number1
Product Code NAY
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS4000 A70P6B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2015
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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