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

Model Number	EGIA30AV
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
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, during the first firing of the device in laparoscopic nephrectomy procedure, they connected reload to the handle.The surgeon clamped the renal vein and pushed the green button and tried to squeeze the handle ,however could not squeeze it.They replaced it with a new reload, and the surgeon clamped the renal vein, however the same event occurred.The sales rep noted some staples of the proximal end were pre-fired.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection noted that the first reload was pre-fired and engaged in interlock with the jaws open.The second reload was received with a full complement of staples.Functional testing of the reloads 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 pre-fired reload was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened, and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the first firing of the device in laparoscopic nephrectomy procedure, they connected reload to the handle.The surgeon clamped the renal vein and pushed the green button and tried to squeeze the handle ,however could not squeeze it.They replaced it with a new reload, and the surgeon clamped the renal vein, however the same event occurred.They then replaced the devices with a new handle and a new cartridge, and the firing was completed with no problem.The sales rep noted some staples of the proximal end were pre-fired.There was no patient injury.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 7439927
• Report Number: 1219930-2018-02075
• Device Sequence Number: 13710861
• Product Code: GDW
• UDI-Device Identifier: 20884521186092
• UDI-Public: 20884521186092
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: 07/31/2022
• Device Model Number: EGIA30AV
• Device Catalogue Number: EGIA30AV
• Device Lot Number: N7G0329KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1