MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI SURGICAL SYSTEM ENDOWRIST STAPLER; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT, STAPLER

Model Number VERSION 09

Device Problems Failure to Fire (2610); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Fenestrated bipolar being used when staff noticed small wire sticking out.A 45mm stapler failed to fire and staff stated that there may be a sharp/blade sticking out of instrument.

• Brand Name: DA VINCI XI SURGICAL SYSTEM ENDOWRIST STAPLER
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT, STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 5041755
• MDR Text Key: 24549343
• Report Number: 5041755
• 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: User Facility
• Reporter Occupation: Other
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: VERSION 09
• Device Catalogue Number: 470298
• Device Lot Number: S1050417 0028
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 93