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

Model Number	TA3048L
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one ta 30-4.8mm single use loading unit.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted the reload had no staples but the pushers were not fully deployed.The pushers were noted to be partially advanced.As part of the functional evaluation the subject cartridge was reloaded with representative staples and fired with a representative ta30 device showing that the unit fired as intended an acceptable staple formation was observed.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Replication of the advanced pusher condition may occur when the firing stroke is not completed during application.The instructions for use of this product state: to fire the instrument, squeeze the handle a second time until it reaches a solid stop and it locks in the back position.If the instrument handle is partially squeezed during firing then released, bleeding may occur as the instrument was not fully fired.The current packaging design for the product does not allow room for advanced staples, thus the condition could not have occurred during assembly or shipment.The root cause of the observed damage was noted to have possibly occurred during use of the product.Should new information become available, the file will be re-opened and the investigation summary will be 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 a procedure, they went to staple the bronchus with the first stapler and the device did not fire.A new reload was used with the same stapler device.The stapler performed open staples (no b sharp) in tissue.Then they changed to another reload and tried to fire out of the patient but nothing happened.Another stapler was opened and that device stapled the tissue without any problem.To correct the issue, the tissue was resected and re-stapled with a new device.There was no 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: 7097202
• Report Number: 2647580-2017-08517
• Device Sequence Number: 1933167
• Product Code: GDW
• UDI-Device Identifier: 10884521043121
• UDI-Public: 10884521043121
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 10/01/2017
• Device Model Number: TA3048L
• Device Catalogue Number: TA3048L
• Device Lot Number: P2K0452X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1