MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL DAVINCI X SUREFORM 45 STAPLE, IMPLANTABLE

Model Number SUREFORM 45

Device Problems Difficult to Remove (1528); Failure to Form Staple (2579); Physical Resistance/Sticking (4012)

Patient Problem Tissue Damage (2104)

Event Date 03/03/2020

Event Type  Injury  

Event Description

Staples and jaw of stapler hooked onto bronchus. Staples had to be removed manually and the stapler pulled back with some resistance to be removed from the pt. Some sharp, incomplete staples had to be removed as well. (ref (b)(4)). Prior to the 7th time to use the davini xi sureform 45, the system reused to recognize the stapler. (ref (b)(4)). Fda safety report ids# (b)(4).

• Brand Name: INTUITIVE SURGICAL DAVINCI X SUREFORM 45
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 9920556
• MDR Text Key: 186542753
• Report Number: MW5094025
• Device Sequence Number: 2
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2021
• Device Model Number: SUREFORM 45
• Device Catalogue Number: 480445
• Device Lot Number: T92190603
• Was Device Available for Evaluation?: No Answer Provided
• 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?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/02/2020 Patient Sequence Number: 1