MAUDE Adverse Event Report: DAVINCI XI ENDO WRIST STAPLER 45 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number XI STAPLER

Device Problems Device Alarm System (1012); Difficult to Remove (1528); Failure to Calibrate (2440); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 01/22/2019

Event Type  malfunction  

Event Description

During a low anterior bowel resection, the intuitive xl stapler malfunctioned. Stapler would not calibrate upon insertion. Stapler was removed, connections cleaned sterile connection plate removed and re attached. Stapler re inserted and would not calibrate over 69%. Stapler removed from robot. Stapler jaw would not open. Manuel key would not open jaw. Stapler removed from service. Remaining lives left on device(44/50 remaining). Stapler load was unable to be removed. Intuitive surgical, inc. , (b)(4).

• Brand Name: DAVINCI XI ENDO WRIST STAPLER 45
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• MDR Report Key: 8281632
• MDR Text Key: 134571580
• Report Number: MW5083418
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: XI STAPLER
• Device Catalogue Number: 470298
• Device Lot Number: T10181017 003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: Yes

Type of Device Usage

Patient Treatment Data

Date Received: 01/25/2019 Patient Sequence Number: 1