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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DA VINCI DA VINCI SURGICAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Pneumonia (2011)
Event Date 10/04/2021
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the reported post-operative complication cannot be determined or is unknown. There is no allegation of a da vinci product malfunction, so no product is expected for return to intuitive surgical, inc. (isi) for failure analysis evaluation. If additional information is received, a follow-up mdr will be submitted. System and instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail. A site history complaint review could not be confirmed due to a lack of product information and procedure dates. No image or procedure videos were provided for review. This complaint is being reported due to the following conclusion: within the journal article titled, ¿heller myotomy perforation: robotic visualization decreases perforation rate and revisional surgery is a perforation risk,¿ postoperative complications involving da vinci surgical procedures were noted. One patient showed a leak on postoperative esophagogram and it was determined that the patient had sustained a perforation while undergoing revisional robotic surgery. The perforation contributed to a prolonged hospital stay. The patient was administered supportive measures, antibiotics, and nutrition. At this time, the root cause of the alleged complication is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.
 
Event Description
Intuitive surgical, inc (isi) became aware of a journal of robotic surgery article titled, ¿heller myotomy perforation: robotic visualization decreases perforation rate and revisional surgery is a perforation risk¿ (engwall-gill, a. J. , soleimani, t. Et al. , 2021). Within the journal article, a post-operative complication involving a da vinci surgical procedure was noted: "only one patient, who was in the robotic group, showed a leak on postoperative esophagram. This directly contributed to her prolonged postoperative stay. This patient had sustained a perforation at her original laparoscopic surgery and then sustained perforation again while undergoing revisional robotic surgery. In this particular case, there was minimal leak of contrast into a contained perforation, which responded to supportive measures, antibiotics, and nutrition. She was hospitalized for a total of 11 days due to an early postoperative complication of pneumonia. " isi has reached out to the author to obtain additional information but has not yet received a response.
 
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Brand NameDA VINCI
Type of DeviceDA VINCI SURGICAL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13036309
MDR Text Key285755409
Report Number2955842-2021-11774
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Literature
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/18/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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