MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN IDRIVE ULTRA; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problems Failure to Advance (2524); Misfire (2532); Device Displays Incorrect Message (2591); Firing Problem (4011)

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

Event Date 07/19/2018

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 third firing for a laparoscopic left hemicolectomy procedure, the surgeon fully fired the device with the reload, and pushed the blue button once again and confirmed the knife did not advance any more.The reload was removed from the tissue ,however it was noted that the distal end of the line was not stapled, and staples stayed at the cartridge.A new reload was connected to the same adapter and handle and the device reacted normally, however, when the surgeon tried to fire the device ,the status indicators illuminated blue.The handle was replaced and connected the same reload however, the same event occurred.The reload was replaced and the firing was successful.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: IDRIVE ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7752464
• MDR Text Key: 116372312
• Report Number: 1219930-2018-04284
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142794
• UDI-Public: 10884521142794
• Combination Product (y/n): N
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1