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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 A60.P6
Device Problem Difficult To Position (1467)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)
Event Date 02/21/2013
Event Type  Injury  
Event Description
It was reported that during a da vinci si partial nephrectomy procedure, the patient side manipulator arm 1 behaved in a sluggish manner. The site contacted isi technical support engineering and indicated that they troubleshot the issue by installing different instruments onto to the affected psm; however, the issue persisted. The or nurse indicated to the tse that they were not very deep into the patient and that they could not observe any interference with the instrument or psm. The site declined further trouble-shooting assistance and indicated that they were going to proceed with the procedure. On (b)(4) 2013, the isi clinical sales representative followed up with the surgeon concerning the reported event. The csr indicated that the surgeon indicated to him that the patient's vena cava was damaged earlier in the procedure and during repair of the patient's anatomy, he experienced articulation issues with the instruments installed on the 1 psm and the 2 psm. The csr indicated that the surgical staff troubleshot the issue by reseating the instruments and the sterile adapters. However, the installed instruments intermittently failed to articulate properly. The csr indicated that the surgeon reported that due to the patient's bleeding he was unable to troubleshoot the issue further. The csr indicated that the surgeon indicated to him that damage to the patient's vena cava was repaired using the da vinci si surgical system and that the planned surgical procedure was also completed with the system. The csr indicated that the site reported that they observed that one of the inner axis insertion posts located on the 1 psm was protruding out and was not flush. No other details concerning this observation were provided to the csr by the site.
 
Manufacturer Narrative
The investigation conducted by the field service engineer (fse) determined that the articulation issue experienced by the site was related to the patient side manipulator arm 1. The psm is an instrument arm located on the patient side cart, which provides the sterile interface for the endowrist instruments. The system was repaired by replacing the affected psm. The psm was returned to isi for failure analysis investigation. Engineering confirmed the customer reported problem and found that the wrist output assembly post heights of axis 4 through axis 7 on the psm were out of specification, thus causing the issue experienced by the site. The psm was repaired by replacing the affected output assembly posts. Engineering evaluation also found that during functional testing of the psm, the psm failed an in-house brake drop test and axis 5 and axis 6 potentiometers had jitter. The main brakes and all of the potentiometers were also replaced in the psm. On (b)(4) 2013, isi contacted the isi clinical sales representative who initially reported the patient injury. The csr indicated that the surgeon indicated to him that damage to the patient's vena cava was not caused by a malfunction of the da vinci si surgical system, instruments and/or accessories; but rather he (surgeon) accidentally nicked the patient's vena cava. Per the csr, the surgeon stated i accidentally got into the patient's vena cava. Per the csr, the surgeon indicated that the articulation issues with the psms occurred while attempting to repair the patient's anatomy. The csr indicated that the surgeon also reported to him that the patient is recovering well and that the patient has not returned to the hospital due to experiencing any post surgical complications as a result of the reported event. As of (b)(4) 2013, there have been no reported recurrences of this failure mode at this hospital. 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.
 
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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.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale, CA 94086
MDR Report Key3024191
MDR Text Key15511484
Report Number2955842-2013-00975
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/25/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60.P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2013
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/25/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2009
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: 03/27/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SURG. SYS., INSTRUMENTS & ACCESSORIES
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