MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI TIP-UP FENESTRATED GRASPER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 470347

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2022

Event Description

Robot tip-up working end missing.Notice after instrument was place into patient.X-ray was performed after case to ensure it was not left in the patient.Fda safety report id# (b)(4).

• Brand Name: DA VINCI XI TIP-UP FENESTRATED GRASPER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 13455121
• MDR Text Key: 285224901
• Report Number: MW5107211
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 470347
• Device Lot Number: K132112213 0183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White