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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A60P9B
Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
The psm was returned for failure analysis, and the reported system error code 23034 was unable to be reproduced. However, the system error code 23034 was confirmed as having occurred via the site's system logs. A visual inspection was performed. The psm was installed onto a system and powered up. A sine cycle and a test drive were performed without any issues. Tests performed via matlab passed. Parts were replaced as a precaution. 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 during a da vinci-assisted inguinal hernia repair procedure, the surgical staff was encountering a non-recoverable fault. Prior to contacting an intuitive surgical, inc. (isi) technical support engineer (tse) for assistance, the initial reporter rebooted the da vinci surgical system a couple of times. The tse reviewed the site's system logs. According to the tse, the system logs showed a system error code 23034 on arm 1 followed by a non-recoverable system error code 307. A system error code 23034 is generated when the system detects a stuck cannula port clutch switch. The tse instructed the site to reboot the system again. However, the same system error occurred again. As a result, the surgeon made the decision to convert the da vinci-assisted inguinal hernia repair procedure to traditional laparoscopic surgery. According to the initial reporter, the event occurred towards the end of the surgical procedure. The surgical procedure was completed successfully via traditional laparoscopic surgery and no post-operative complications have been reported. On (b)(4)2017, an isi field service engineer (fse) performed a field evaluation at the site. The fse was able to reproduce the customer reported failure mode and replaced the patient side manipulator 1 (psm1) to resolve the issue. The psm is an instrument arm located on the patient side cart (psc) that provides sterile interface for the endowrist instrument.
 
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Brand NameDA VINCI SI 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 Key7028485
MDR Text Key93098885
Report Number2955842-2017-00768
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
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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