MAUDE Adverse Event Report: INTUITIVE SURGICAL, DA VINCI SURGICAL SYSTEMS DA VINCI S; PROGRASP FORCEPS 8MM

Catalog Number 420093

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/13/2017

Event Type  No Answer Provided  

Event Description

Performing hysterectomy robotic surgery, at conclusion of surgery wire was found in surgical site.Suspected from robotic instrument.

• Brand Name: DA VINCI S
• Type of Device: PROGRASP FORCEPS 8MM
• Manufacturer (Section D): INTUITIVE SURGICAL, DA VINCI SURGICAL SYSTEMS
• MDR Report Key: 7137503
• MDR Text Key: 95497074
• Report Number: MW5074145
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/15/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Device Operator: Health Professional
• Device Catalogue Number: 420093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR