MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-50

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

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the reported post-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, there are no products expected for the return to intuitive surgical, inc.(isi) for failure analysis evaluation.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted on 29-dec-2021 and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.Additionally, all instruments used in the case were used in a subsequent procedure.This complaint is being reported due to the following: after a da vinci-assisted ventral hernia repair, the patient was readmitted to the hospital for complaints of pain and bleeding in the small bowel.The patient underwent a bowel resection and is recovering.The cause of the post-operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

It was initially reported that after undergoing a da vinci-assisted ventral hernia repair, a female patient with a history of unspecified bowel surgeries/procedures, was readmitted to the hospital for complaints of stomach pain and excessive bleeding in the small bowel.The patient underwent an open procedure with a bowel resection.According to the intuitive surgical, inc (isi) clinical sales representative (csr), the surgeon believes that the bowel injury was possibly related to the da vinci-assisted ventral hernia repair; however, no patient injury occurred intraoperatively and the procedure was completed robotically as planned.The patient¿s current status was that she was recovering well.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 13565398
• MDR Text Key: 289963839
• Report Number: 2955842-2022-10303
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female