MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI SI PROGRASP FORCEPS

Catalog Number 420093-11

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2017

Event Type  Other  

Event Description

Jaws came apart during surgery, instrument grip pin failure.No patient harm.

• Brand Name: DA VINCI SI PROGRASP FORCEPS
• Type of Device: DA VINCI SI PROGRASP FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7104545
• MDR Text Key: 94506814
• Report Number: MW5073881
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 420093-11
• Device Lot Number: N10160628-624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2017
• 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