MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI ENDOWRIST STAPLER; DA VINCI XI ENDOWRIST STAPLER 45

Catalog Number 470298-11

Device Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  Other  

Event Description

Stapler would not recognize or "read" staple reload, multiple times.Re-seated sterile drape adapter several times without success.Drape performance and reload recognition failure.No patient harm.

• Brand Name: DA VINCI XI ENDOWRIST STAPLER
• Type of Device: DA VINCI XI ENDOWRIST STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7104521
• MDR Text Key: 94504863
• Report Number: MW5073878
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 470298-11
• Device Lot Number: S10160815-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• 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