MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. MARYLAND BIPOLAR FORCEPS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 420172

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

Maryland bipolar forceps was docked and in pt's abdomen.Pt noted there was a wire sticking out of the instrument.Instrument was removed from pt.No harm to pt.(b)(4).

• Brand Name: MARYLAND BIPOLAR FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; 1266 kifer road; bldg 101; sunnyvale CA 94086 5304
• MDR Report Key: 7572980
• MDR Text Key: 110361195
• Report Number: MW5077651
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420172
• Device Lot Number: N101710090420172-14
• Was Device Available for Evaluation?: Yes
• 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: 73 YR