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

Model Number 470530

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

This stapler was being used during a robotic case, and when the surgeon asked for it to be removed from the trocar within the pt, the handpiece would not release from the robotic carrier/arm.The buttons on the handpiece did not appear to work.The stapler release kit was opened and used to no avail.After several attempts to remove the handpiece from the robotic arm, the surgical tech was able to remove it with force.The stapler was not clamped on the pt's tissue at the time, and the pt was not injured during this time.Devices will be returned only if mfr provides prepaid shipping, packaging as per dot, or pick the item up.The details in the report is the extent to which we identify medications involved or pt contact.

• Brand Name: STAPLER 30 CURVED TIP
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC.
• MDR Report Key: 7885220
• MDR Text Key: 120826936
• Report Number: MW5079858
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470530
• Device Lot Number: S10170307 0014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 81 YR