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

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.

• Brand Name: DAVINCI
• Type of Device: DA 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 Key: 13025820
• MDR Text Key: 285624688
• Report Number: 2955842-2021-11760
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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 Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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 Number: N/A

Patient Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES