MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG45CTAV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operative a video assisted thorascopic right lower lobectomy, the patient had to return to theatre 6 hours after surgery to investigate 1 litre of blood loss in chest drain and management of bleeding.The pulmonary artery was found to have pulsatile bleeding through the center of vessel.The bleeding was reported to be a single spurt of blood coming through the center of the staple line.A clip was placed on the artery to control the bleeding.It was reported that the surgical time was extended by one hour.No further events have been reported and patient was reported to be doing well.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10412866
• Report Number: 1219930-2020-03372
• Device Sequence Number: 3868957
• Product Code: GDW
• UDI-Device Identifier: 10884521543706
• UDI-Public: 10884521543706
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SIG45CTAV
• Device Catalogue Number: SIG45CTAV
• Device Lot Number: N8M0494Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR