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

Model Number	EGIATRS45AXT
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
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, when the device was used for bullae resection of the lung emphysema's apical part in thoraco/pneumothorax procedure, the event occurred at the third firing.The surgeon felt that the tissue were thick and the firing was stiff.The third firing approached at an angle orthogonal to the second firing's staple line without articulating.The jaws opened and the surgeon was unable to close it, so surgeon pressed the fire button while squeezing the handle.Surgeon attempted to fire but the staples did not advance so a reload was replaced.When the surgeon attempted to fire, an abnormal sound was heard.The handle could not be returned from the squeezing position, so surgeon released it and replaced the handle.The leak test was also finished without abnormality and the operation was completed.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted that the reload was pre-fired and engaged in interlock with the jaws open.Functional testing of the reload found no abnormalities.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.

• 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: 8175945
• Report Number: 1219930-2018-06719
• Device Sequence Number: 11199409
• Product Code: GDW
• UDI-Device Identifier: 10884521190993
• UDI-Public: 10884521190993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 08/31/2020
• Device Model Number: EGIATRS45AXT
• Device Catalogue Number: EGIATRS45AXT
• Device Lot Number: N7H0541KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1