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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 Problem Poor Quality Image (1408)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
Isi has received the camera head involved with this complaint and completed investigations. Failure analysis inspected the camera head and was unable to replicate or confirm the customer reported complaint of double-vision. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2016. No related system errors were found to have occurred during the surgical procedure. This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the patient sustained a rectal tear injury. However, the root cause of the intra-operative complication is unknown. It is unclear if the customer reported vision issue caused/contributed to the intra-operative complication.
 
Event Description
It was initially reported that during a da vinci-assisted prostatectomy procedure, the surgical staff encountered a double-vision issue. There were no reports of any patient harm according to the initial reporter, a robotics coordinator. On 12/15/2016, intuitive surgical, inc. (isi) contacted the site's risk manager and obtained the following information regarding the reported event. It was reported that during the surgical procedure, the surgeon encountered a double-vision issue with the da vinci si surgical system and was experiencing migraine-like symptoms. The isi clinical sales representative (csr) used a backup camera to replace the camera of the patient side cart (psc). The risk manager stated that patient harm occurred during the surgical procedure. However, the risk manager did not have access to the patient's records and could not provide additional details regarding the patient harm. Isi also contacted the isi clinical sales representative (csr). The csr indicated that he was at another hospital and in the middle of another da vinci-assisted surgical procedure when the robotics coordinator called him for assistance with the double-vision issue. According to the csr, at that time, the robotics coordinator admitted that she had not called isi technical support. Instead of calling isi technical support, the robotics coordinator requested for the csr to come to the site and provide assistance. When the csr arrived in the or, he reportedly noticed that a general surgeon was sitting at the surgeon side console (ssc) instead of the urology surgeon who was performing the da vinci-assisted prostatectomy procedure. When he looked at the vision side cart (vsc), he confirmed that the surgical staff was experiencing the reported double-vision issue with the da vinci system. Also, based on the image seen on the vsc, the csr believed that the surgical staff was viewing the patient's rectum. However, the csr did not know why the general surgeon was sitting at the console and why the surgical staff was viewing the patient's rectum. After the robotics coordinator found a backup camera in her office, the csr assisted the surgical staff with replacing the camera on the psc. The backup camera resolved the reported double-vision issue and the surgical procedure was completed successfully. On 01/12/2017, the site's risk manager contacted isi and provided the following additional information regarding the reported event: the patient sustained a rectal tear during the da vinci-assisted surgical procedure. As a result of the intra-operative complication, the patient required a diverting colostomy. At this time, the surgeon is currently waiting to see if the diverting colostomy can be reversed or will remain permanent. The risk manager indicated that the patient is doing well at this time. The risk manager was unable to provide a root cause for the rectal tear injury.
 
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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 Key6249729
MDR Text Key64760282
Report Number2955842-2017-00029
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
Type of Report Initial
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/13/2017 Patient Sequence Number: 1
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