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

Model Number EGIA45AMT

Device Problems Unintended Head Motion (1284); Human-Device Interface Problem (2949)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, while transecting the stomach with the device and near the end of the staple firing during a robotic laparoscopic esophagectomy procedure, the shaft of the device began spinning uncontrollably.The tissue was pulled but did not result in significant injury.The surgeon was able to retract the knife blade, and open the jaws of the reload with the device, which stopped the spinning.Then they took the stapler out and put it on the back table.The tech was not able to unload the reload.After they failed to unload the reload, they looked at the lights and said they saw 5 solid white lights on the device.A new device was opened and processed to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device and a photographic evaluation of one reload.A visual inspection of the returned photos noted the reload was not properly locked onto the adapter.The proximal end of the adapter was broken and the articulation flag was bent.Functional testing could not be performed due to the noted damages.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Additionally, the investigation detected a secondary condition of a broken adapter that has no relationship to the reported condition.Replication of the damaged reload adapter may occur due to over flexure of the reload while attached to the instrument.No further actions have been deemed necessary at this time.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 CT 06473
• MDR Report Key: 7534284
• MDR Text Key: 108922253
• Report Number: 1219930-2018-02822
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003154
• UDI-Public: 10884523003154
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Device Lot Number: N8C0777KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1