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

Model Number 380652-50

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Death  

Manufacturer Narrative

The following devices were used during the procedure: 30 degree endoscope plus, monopolar curved scissors, tenaculum forceps, fenestrated bipolar forceps.A site review found that no complaints have been reported for any of these products.A review of the event was performed by an intuitive surgical medical safety officer (mso) who concluded that according to a social media post, a patient expired following a da vinci robotic myomectomy procedure.The social media post suggested a urethral injury contributed to this event.Anatomically, the urethra is not usually in the resection or working area of a myomectomy although the ureter can be inadvertently injured in a myomectomy regardless of the modality used for the resection.Because this was a social media post, the details of the information is limited and accuracy is unknown.Furthermore, the exact details of how this injury occurred, how the da vinci may or may not have been involved, and how and when this injury may have led to the patient¿s death are unknown.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive surgical instruments or products contributed to this event.Section e: this complaint was learned of via a social media post.The address provided in section e is the address of the distributor that learned of the event.

Event Description

It was discovered via a social media posting by the patient¿s sister that during a da vinci-assisted myomectomy procedure, a perforation occurred to the patient's "urethra [ureter], which meant that the urine, instead of going into the bladder, fell into the abdominal cavity.She was discharged and went home [this] led to an infection that, in a matter of days, became generalized.¿ the patient expired at a different hospital than where they underwent the da vinci procedure.Attempts to obtain additional information are ongoing; however, have not been successful.

Manufacturer Narrative

Review of the system logs for the reported procedure date found no system errors occurred during the procedure.A review of the logs for the five subsequent procedures found no relevant errors.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 19149629
• MDR Text Key: 340673162
• Report Number: 2955842-2024-13725
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Female