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

Model Number EGIA45AVM

Device Problems Failure to Advance (2524); Failure to Fire (2610); Firing Problem (4011)

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

Event Date 07/09/2018

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 an open total gastrectomy r-y procedure, for lifting the jejunum up, they connected the reload to the adapter and checked the jaws opening/closing with no problem.Then the surgeon tried to fire the device, however the clamp cover did not advance from the proximal end of the reload and could not fire the device.The display screen showed indicator of the used shell attached.The surgeon removed the cartridge from the tissue with no problem.They replaced it with another handle and a new shell, and connected the same reload; however the surgeon could not fire the device.They replaced it with another reload (the second one); however the surgeon still could not fire the device.They replaced the handle with a third one and another new shell (the third one), and connected the reload (the second one) however the surgeon could not fire the device.They replaced the handle with a different one (fourth handle), and connected the reload (the second one), however the surgeon could not squeeze the handle and could not fire the device.They replaced the device with another new reload (third one), and connected the same handle (fourth one), and the firing was successful.The surgical time was extended by more than 30 minutes.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the returned product noted that the reload was fully fired.Staple pushers were visible at the zero cut line.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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 CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7714175
• MDR Text Key: 114973085
• Report Number: 1219930-2018-04019
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003178
• UDI-Public: 10884523003178
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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 Expiration Date: 04/30/2023
• Device Model Number: EGIA45AVM
• Device Catalogue Number: EGIA45AVM
• Device Lot Number: N8D0806KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 08/08/2018
• Supplement Dates FDA Received: 09/18/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1