MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI 45MM ENDO WRIST STAPLER RELOAD; STAPLE IMPLANTABLE

Catalog Number 48445G

Device Problem Defective Component (2292)

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

Event Date 10/17/2019

Event Type  Injury  

Event Description

Staple line failed during bronchial reinflation.

• Brand Name: DA VINCI XI 45MM ENDO WRIST STAPLER RELOAD
• Type of Device: STAPLE IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 9234596
• MDR Text Key: 164073055
• Report Number: MW5090631
• Device Sequence Number: 1
• Product Code: GDW
• 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: 10/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 48445G
• Device Lot Number: M1181003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 57