MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE

Model Number	TA6048L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	08/28/2019
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, during an open lobectomy, to cut some parenchyma, the staples did not deploy, the device cuts the tissue.They closed with very thick tissue and did not see the stapler from the anvil side so they cannot say how the stapler was closed.They closed the stapler (handle to handle) and then cut the tissue with a knife.When they opened the stapler they saw some of the staple line was closed properly, however around 3 cm of staples were not closed and they had bleeding, which has to be stopped with sutures and two other cartridges to close the parenchyma.The device was fired and staples was closed properly in distal half 40% from the pin.The staples were open proximal to the pin.The operation was longer than thirty minutes.There was patient injury.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9107999
• Report Number: 2647580-2019-04736
• Device Sequence Number: 16640405
• Product Code: GDW
• UDI-Device Identifier: 20884521043227
• UDI-Public: 20884521043227
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 06/30/2023
• Device Model Number: TA6048L
• Device Catalogue Number: TA6048L
• Device Lot Number: P8F1193MX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/24/2019
• 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