MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number 480460

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Event Description

The sureform 60 robot stapler was loaded with a black load and seamguard and successfully fired.A second staple load (green) was loaded with seamguard and also successfully fired.Upon loading the third staple load (also green with seamguard) the surgeon received an error message "failure of stapler to initialize".The instrument drape was double checked to assure the plate was engaged and a new staple load was loaded without success.A second sureform 60 stapler arm was opened and loaded in the same fashion and was successfully fired.The second stapler continued to successfully fire for the remainder of the case.The case was completed robotically.No harm was done to the patient and the defective stapler was observed to be intact after removal from the patient.Intuitive rep was present for the entire case.Manufacturer response for sureform 60 robot stapler, sureform 60 robot stapler (per site reporter).The manufacturer representative was present during this event.

• Brand Name: SUREFORM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 9659186
• MDR Text Key: 177372884
• Report Number: 9659186
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 480460
• Device Lot Number: L90191023 VER8
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA