MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE XI STAPER 30 CURVED; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number 470520

Device Problems Failure to Form Staple (2579); Material Protrusion/Extrusion (2979)

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

Event Date 07/24/2019

Event Type  malfunction  

Event Description

Stapler failed when stapling bronchus.Blade was left exposed.Tissue was halfway out, requiring emergent switching to a black 60 stapler.

• Brand Name: INTUITIVE XI STAPER 30 CURVED
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 8855317
• MDR Text Key: 153278237
• Report Number: MW5088640
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470520
• Device Lot Number: S10161227-0015
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 64 YR
• Patient Weight: 92