MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR XI; SYSTEM, SURGICAL, COMPUTER-CONTROLLED INSTRUMENT

Model Number 470205

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Intuitive davinci fenestrated bipolar xi would not activate during procedure.

• Brand Name: FENESTRATED BIPOLAR XI
• Type of Device: SYSTEM, SURGICAL, COMPUTER-CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9769509
• MDR Text Key: 181374849
• Report Number: 9769509
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 470205
• Device Catalogue Number: 470205
• Device Lot Number: N101904140182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA