MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG IDRIVE ULTRA; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problems Unintended Arm Motion (1033); Unintended Movement (3026)

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

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the second firing on the stomach on a laparoscopic gastric bypass procedure, the jaws opened and then close then the stapler start to move without commands.There was a problem loading the reload onto the adaptor also.The handle did not recognize the reload.The stapler did not fire.The surgeon was not able to press the green button and squeeze the handle.There was no patient injury.

• Brand Name: IDRIVE ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7203971
• MDR Text Key: 97859164
• Report Number: 1219930-2018-00433
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142794
• UDI-Public: 10884521142794
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 117