MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI TIP COVER ACCESSORY; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 400180

Device Problems Entrapment of Device (1212); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2019

Event Type  Injury  

Event Description

Tip cover was missing from robotic scissor when removed from pt trocar during robotic surgery.Efforts made to locate with no avail.Pt was brought back to surgery on (b)(6) 2019 to remove retained top cover.Fda safety report id# (b)(4).

• Brand Name: DA VINCI TIP COVER ACCESSORY
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 9525932
• MDR Text Key: 173193546
• Report Number: MW5091913
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 400180
• Device Lot Number: M92190705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 39 YR
• Patient Weight: 58