MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI ENDOWRIST; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number DA VINCI XI

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Part of robotic needle driver broke off during surgery; attempt to localize with fluoroscopy was unsuccessful.A robotic repair for an umbilical hernia was being performed.While closing the incision within the abdomen, it was noted that a portion of the tip of the robotic needle driver broke off.The surgeons did not see the instrument break, but it was recognized when using the instrument again.The tip of the jaw had broken off.The size is very small.Approximately 3x3 mm with a rounded end except where it broke off.The surgeons then used x-rays to locate it.Although they could see it on x-ray, they were not able to locate it within the loops of intestine because it was so small.It should be noted that there were adhesions from prior surgery and treatment that prohibited the surgeons from exploring all areas where the tip could have moved to.The surgeon decided to abort the operation because the risk of injuring the intestines was greater than the risk of the tip of the instrument causing harm to the patient by injuring the intestines or other vital structure.After the patient was recovered from anesthesia, the surgeon discussed the event with the patient.Fda safety report id # (b)(4).

• Brand Name: DA VINCI XI ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 12852277
• MDR Text Key: 281196522
• Report Number: MW5105495
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119815
• UDI-Public: 00886874119815
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: N11210818
• Device Lot Number: N112108180061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White