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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 S A5.1P8
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 02/12/2013
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2013, isi contacted the isi clinical sales representative (csr) assigned to the site. The csr indicated that he spoke to the (b)(6) at the hospital. Per the csr, the (b)(6) indicated to him that the da vinci s hysterectomy procedure was successfully completed and that there were no intra-operative complications experienced by the patient. The csr indicated that the or director indicated to him that the patient developed unspecified post-operative complications; however, the (b)(6) was unable to provide the date/time that the patient began to experience the post-operative complications. The csr indicated that the or director indicated to him that the date of the surgical procedure is unknown; however, no malfunction of the da vinci s surgical system, instruments, or accessories occurred during the surgical procedure. The csr indicated that the (b)(6) indicated to him that the patient underwent a laparoscopic procedure at the hospital and it was discovered that sutures were stuck to the patient's large colon and that upon removal of the sutures, a perforation of the patient's large colon was discovered and that the affected area was repaired. The csr indicated that the (b)(6) was unable to provide him with information regarding the current status of the patient. Based on the information provided by the site, it is indeterminable as to what caused or contributed to the injury sustained by the patient. Intuitive surgical has continued to request additional information from the site regarding this event; however, as of the date of this report no additional information or response has been provided. A follow-up mdr will be submitted to the fda if additional information is received.
 
Event Description
It was reported that post a da vinci s hysterectomy procedure, it was discovered that the patient sustained rectal/colon injuries, which required the patient to undergo additional surgical procedures.
 
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Brand NameDA VINCI S 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 Key3005215
MDR Text Key10678521
Report Number2955842-2013-00828
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081207
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 02/12/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIS2000 S A5.1P8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/12/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2010
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: 03/14/2013 Patient Sequence Number: 1
Treatment
DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE
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