MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI 45MM STAPLER

Catalog Number 470298

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 05/31/2018

Event Type  malfunction  

Event Description

A 45mm davinci stapler made by intuitive was not recognized by the pt cart.After several attempts, product was recognized and fired without incident.Instrument was reloaded and inserted into pt again.Not able to recognized instrument and the stapler jaw is locked shut, stapler load unable to be removed.

• Brand Name: DAVINCI 45MM STAPLER
• Type of Device: 45MM STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA
• MDR Report Key: 7709832
• MDR Text Key: 114818948
• Report Number: MW5078497
• Device Sequence Number: 1
• Product Code: GAG
• 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: 05/31/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470298
• Device Lot Number: T11171031
• 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: 48 YR