MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST MONOPOLAR CURVED SCISSORS; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 420179 VER 15

Device Problems Sticking (1597); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Event Description

Doctor was performing a dtlh.He asked for the scissor to be removed from the field.The scissor was stuck in the trocar.Doctor had to scrub in to loosen the scissor.The grey plastic tip was rolled down and doctor had to use a pair of hemostats to pull the scissors out.No harm done to patient.Scissor removed from field and sent to the company for testing.

• Brand Name: ENDOWRIST MONOPOLAR CURVED SCISSORS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6518762
• MDR Text Key: 73606828
• Report Number: 6518762
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 420179 VER 15
• Device Lot Number: N12170217 717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR