MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI COBRA GRASPER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 00886874121481

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

The wire broke on the cobra instrument, was taken off the field.Fda safety report id # (b)(4).

• Brand Name: DAVINCI COBRA GRASPER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 12689258
• MDR Text Key: 278534759
• Report Number: MW5104914
• Device Sequence Number: 1
• Product Code: NAY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00886874121481
• Device Lot Number: N102105240011
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR