MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; PATIENT SIDE CART

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Injury (2348)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Site research was conducted on 10-nov-2020 and did not confirm a site location or system information with the information on file at this time.A review of the system and instrument logs could not be performed due to the lack of system and instrument information on file at this time.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is reportable due to the following: it was alleged that a patient sustained a ¿trocar injury¿ and ¿bowel necrosis¿ six to seven days post a da vinci-assisted surgical procedure for which ¿repair¿ and additional hospitalization were required.However, at this time, the root cause of the reported issue is unknown.

Event Description

It was reported via a general physician inquiry that after a completed da vinci-assisted gynecology procedure, possibly on (b)(6) 2019, patient injury was reported.The patient returned to the hospital six to seven days post da vinci procedure, possibly on (b)(6)2019, for what was described as ¿repair¿ as there was an observed ¿trocar injury¿ and ¿bowel necrosis¿.Further detail was unknown.The patient¿s current status is also unknown.

• Brand Name: DA VINCI
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10947801
• MDR Text Key: 219866555
• Report Number: 2955842-2020-11298
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/04/2020
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other