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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 Insufficient Information (3190)
Patient Problems Embolism (1829); Internal Organ Perforation (1987); Blood Loss (2597)
Event Date 03/23/2017
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, isi has not determined the root causes for the alleged post-operative complications experienced by the patient. It is unknown if the gastric perforation occurred during the diagnostic laparoscopy procedure or the da vinci-assisted surgical procedure. Isi has attempted to contact the site to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report. A follow-up mdr will be submitted if additional information is received. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2013. No related system errors were found to have occurred during the da vinci surgical procedure. Each reusable (multi-use) instrument used during the da vinci surgical procedure has been used in subsequent surgical procedures without any reported issues. This complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient was found to have sustained a gastric perforation, developed an unspecified embolism, and experienced a gi bleed. However, at this time, the root causes of the -postoperative complications are unknown.
 
Event Description
It was reported that after undergoing a da vinci-assisted ventral hernia repair procedure, the patient was found to have sustained a gastric perforation on post-operative day 1. Prior to undergoing the da vinci-assisted surgical procedure, the patient had also undergone a diagnostic laparoscopy procedure with adhesiolysis. A surgeon repaired the gastric perforation via open surgery and had to remove mesh. After going home, the patient reportedly developed an unspecified embolism and gi bleed. No further clinical information was provided.
 
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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 Key6547806
MDR Text Key74584454
Report Number2955842-2017-00277
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 04/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
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: 05/05/2017 Patient Sequence Number: 1
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