MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIAADAPT

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 two 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 endo gia adapter std.No visual abnormalities were noted.The electrically erasable programmable read-only memory (eeprom) was uploaded and indicated 24 autoclave cycles for the adapter.A pmv representative single use loading unit (sulu) was inserted onto the adapter with a pmv drive handle and battery.The green light signaling the attachment of the adapter illuminated indicating that the adapter was recognized.The reload cycled properly and was applied to test media where it was able to apply the staple line and transect the media without difficulty.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7431064
• MDR Text Key: 105516878
• Report Number: 1219930-2018-02019
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521142800
• UDI-Public: 10884521142800
• 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: 10/04/2018

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: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• 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