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

Model Number IDRVULTRA2

Device Problem Unintended Head Motion (1284)

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

Event Date 03/23/2018

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 robot assisted laparoscopic lobectomy, before entering the trocar which was not on the patient and when the reload was placed, there were 2 devices that started to calibrate, started spinning and would not stop after the adapter was taken off.A new powered stapler was used to complete the case.There was no patient injury in this event.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation replicated the reported condition of the handle not calibrating correctly.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a component error was identified during product analysis.The observed failure was most likely caused by an internal break in connection on the brushless direct current (bldc) board leading to intermittent occurrences where the drive motor could not successfully complete calibration.The bldc board has been identified to be susceptible to damage to inter-connect due to heat stress at the solder station.The product analysis established a relationship between a device failure and the reported incident of received light sequence to replace the handle.The root cause of the observed condition was determined to be a result of a manufacturing activity and a product enhancement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.

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: 7430544
• MDR Text Key: 105518174
• Report Number: 1219930-2018-02012
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521510579
• UDI-Public: 10884521510579
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA2
• Device Catalogue Number: IDRVULTRA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1