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 07/13/2018

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 gastrectomy, they connected the reload to the handle, then the surgeon tried to fire the device, however could not.The sales rep checked the cartridge in question and noted the staple pusher was slightly pushed and sled was slightly advanced.The procedure was completed with another device.There was no patient harm.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 3 cm cut line.Functionally the reload was loaded into a post market vigilance instrument, the interlock was over ridden, and the reload was applied to test media.All remaining staples were placed, and test media was cleanly transected.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 partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the loading unit will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection, and prevent patient harm.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.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 mc dermott rd; north haven CT 06476
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06476
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7733387
• MDR Text Key: 115647516
• Report Number: 1219930-2018-04182
• 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: 12/11/2018

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: 02/28/2023
• Device Model Number: EGIA45AVM
• Device Catalogue Number: EGIA45AVM
• Device Lot Number: N8B0412KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 11/17/2018
• Supplement Dates FDA Received: 10/02/2018; 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2018
• 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