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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI DA VINCI XI SURGICAL SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI XI DA VINCI XI SURGICAL SYSTEM Back to Search Results
Model Number IS4001-01
Device Problem Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Injury (2348)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, isi has not determined the root causes of the operative complications experienced by the patient. There is no allegation that a malfunction of the da vinci xi surgical system occurred. If additional information is received, a follow-up mdr will be submitted. The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed. Based on the available system logs, no related system errors were found to have occurred during the surgical procedure. Based on the information provided at this time, this complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, a stomach perforation, esophagus perforation, and mesh displacement were identified. However, the root causes of the operative complications are unknown.
 
Event Description
It was initially reported that a patient underwent a da vinci-assisted surgical procedure and the following complications were reported: stomach perforation, esophagus perforation, and mesh displacement. The patient reportedly underwent multiple surgeries and was not doing well. On 21-may-2018, intuitive surgical, inc. (isi) contacted the initial reporter, an isi clinical sales representative, who was present during the first 1. 5-2. 0 hours of the da vinci-assisted surgical procedure. The csr indicated that the patient had previously undergone a nissen fundoplication procedure via traditional laparoscopic surgery. However, the csr did not know what date the traditional laparoscopic surgery was performed, what hospital the surgery was performed, and if the patient experienced any operative complications related to the traditional laparoscopic surgical procedure. In this case, the csr indicated that the patient was undergoing a ¿re-do¿ of the nissen fundoplication procedure via robotic surgery. The csr was informed by a ¿nurse assist¿ and a ¿tech¿ from the hospital of the operative complications. However, the csr did not know the causes of the operative complications. There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
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Brand NameDAVINCI XI
Type of DeviceDA VINCI XI SURGICAL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7557022
MDR Text Key109685267
Report Number2955842-2018-10241
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 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIS4001-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/31/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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