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

Model Number XI

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

This maryland bipolar xi instrument was returned to me with a blank fixt it tag.The tips of the instrument appear to be offset and a black cable is protruding.There was no indication from our logs that anything untoward occurred during the last documented case where this instrument was used.There were 4/10 lives remaining on the reposeable instrument.Fda safety report id # (b)(4).

• Brand Name: DA VINCI XI MARYLAND BIPOLAR FORCEP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 11207333
• MDR Text Key: 228215439
• Report Number: MW5098898
• Device Sequence Number: 1
• Product Code: NAY
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XI
• Device Catalogue Number: 470172 VER14
• Device Lot Number: N10170815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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