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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC DAVINCI DA VINCI SURGICAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
It was reported by a surgeon that a patient underwent an unspecified da vinci-assisted surgical procedure and sustained a major bile duct injury. No further details were provided. The procedure name, event date, da vinci system information, and cause of the alleged injury are unknown. Intuitive surgical, inc. (isi) has attempted to contact the surgeon to gather additional information about the reported complaint. However, no further details have been received at this time.
 
Manufacturer Narrative
Based on the current information provided, the root cause of the alleged operative complication cannot be determined or is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. If additional information is received, a follow-up mdr will be submitted. A site history review was unable to be conducted at this time due to lack of system and instrument detail as well as the event/procedure date. There was no image or video clip supplied for review related to a specific event. Neither a system nor instrument log review could be performed due to lack of system, procedure, and instrument detail. Based on the information provided at this time, this complaint is being reported due to the following: a patient underwent an unspecified da vinci-assisted surgical procedure and allegedly sustained a major bile duct injury. At this time, additional event and procedure details, severity of the complication, specific medical intervention required, and root cause of the alleged complication are unknown. There is no allegation that a malfunction of a da vinci surgical system occurred. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. Field is blank because the date of the event was not available. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Field is blank because it is unknown if the initial reporter submitted a report to the fda. Fields are not applicable. Field is blank because insufficient product information was provided in order to obtain the date of manufacture.
 
Manufacturer Narrative
Based on the current information provided, the root cause of the alleged operative complication cannot be determined or is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred. If additional information is received, a follow-up mdr will be submitted. A site history review was unable to be conducted at this time due to lack of system and instrument detail as well as the event/procedure date. There was no image or video clip supplied for review related to a specific event. Neither a system nor instrument log review could be performed due to lack of system, procedure, and instrument detail. Based on the information provided at this time, this complaint is being reported due to the following: a patient underwent an unspecified da vinci-assisted surgical procedure and allegedly sustained a major bile duct injury. At this time, additional event and procedure details, severity of the complication, specific medical intervention required, and root cause of the alleged complication are unknown. There is no allegation that a malfunction of a da vinci surgical system occurred. Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable. Field is blank because the date of the event was not available. The expiration date for section is not applicable. Field is blank because the product is not implantable. Information for the blank fields in section is not available. Field is blank because it is unknown if the initial reporter submitted a report to the fda. Fields are not applicable. Field is blank because insufficient product information was provided in order to obtain the date of manufacture.
 
Event Description
It was reported by a surgeon that a patient underwent an unspecified da vinci-assisted surgical procedure and sustained a major bile duct injury. No further details were provided. The procedure name, event date, da vinci system information, and cause of the alleged injury are unknown. Intuitive surgical, inc. (isi) has attempted to contact the surgeon to gather additional information about the reported complaint. However, no further details have been received at this time.
 
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Brand NameDAVINCI
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 Key13025820
MDR Text Key285624688
Report Number2955842-2021-11760
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,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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 Received11/19/2021
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: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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