MAUDE Adverse Event Report: INTUITIVE SURGICAL INTUITIVE SURGICAL; SYSTEM SURGICAL COMPUTER CONTROLLED INSTRUMENT

Model Number 410322

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Event Description

During procedure, vessel sealer occurred with recoverable fault with blade fully exposed.Vessel sealer removed from robot and replaced with new sealer.No pt harm."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: INTUITIVE SURGICAL
• Type of Device: SYSTEM SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA
• MDR Report Key: 6736182
• MDR Text Key: 80902980
• Report Number: MW5071164
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Lot Number: M10170425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• 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 Age: 50 YR