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

Model Number	EGIA30CTAV
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: at the first firing of lobectomy, the surgeon connected the reload to a handle and checked the jaws opening/closing.Then the surgeon tried to fire the device, however could not.The procedure was completed with another device.No patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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 pre-fired and engaged in interlock.There were staples protruding from proximal staple cartridge channel.Functionally the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was applied to test media with proper staple placement and media transection.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 pre-fire condition with interlock engagement may occur if the instrument firing handle had been partially compressed and released after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time 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.
Event or Problem Description
According to the reporter, at the first firing of lobectomy, the surgeon connected the reload to a handle and checked the jaws opening/closing.Then the surgeon tried to fire the device however could not.Also, the surgeon was not able to squeeze the handle although the surgeon was able to press the green button.The procedure was completed with another device.There was no patient injury.The sales rep did not find the evidence of the pre-firing of the reload.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7710503
• Report Number: 1219930-2018-03991
• Device Sequence Number: 756880
• Product Code: GDW
• UDI-Device Identifier: 20884521186108
• UDI-Public: 20884521186108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: EGIA30CTAV
• Device Catalogue Number: EGIA30CTAV
• Device Lot Number: N7M0194KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 08/08/2018; 08/08/2018; 11/17/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/03/2018; 10/03/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1