MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI PROGRASP FORCEPS; SYSTEM, SURGICAL

Model Number 470093

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Surgeon was using robotic prograsp forceps when internal wire for device broke.Instrument stopped working, instrument was removed from robot port and removed from field.Surgeon continued procedure without incident.

• Brand Name: DAVINCI PROGRASP FORCEPS
• Type of Device: SYSTEM, SURGICAL
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 6438927
• MDR Text Key: 71202043
• Report Number: MW5068691
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470093
• Device Lot Number: N10161003-0063
• 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
• Patient Weight: 77