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

Model Number IDRVULTRA1

Device Problems Unintended Head Motion (1284); Misfire (2532); Difficult to Open or Close (2921)

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

Event Date 06/12/2018

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 a video-assisted thoracic surgery lobectomy, while the device was being applied to the pulmonary vein, when the device was fired, it stopped at the central part.After that, its adapter rotated automatically without any manipulation.The jaws of the device locked on tissue.The product was changed to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one (1) device.Visual and functional evaluation of the handle noted no abnormalities.Evaluation of the eeprom noted that the code drive_motor_excessive_load_mode was present.This was indicative of a thick tissue application and could confirm the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the drive_motor_excessive _load_mode error codes may occur of the powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the reload.This may occur under the following conditions.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In either scenario, staples may not form properly and tissue may not be fully transected.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: 7641659
• MDR Text Key: 112457509
• Report Number: 1219930-2018-03438
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1