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

Model Number	SIGTRS45AXT
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
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 at fifth firing during a lung parenchyma resection on a thoracoscopic video assisted surgery, the surgeon was able to squeeze the handle; however, the anchoring suture on the cartridge side was disengaged.As a result, the lung parenchyma and the cartridge could not be separated but the sheet came off without any problems.A forceps and scissors were used to cut the tissue by force to be removed from the device.No tissue damage.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the pushers were all fired, but the sled was not fully advanced.The jaws were open.The distal suture on the anvil side was still anchored on reinforcement material.Functionally the reload was loaded into a pmv representative instrument, the interlock was overridden, and the reload was cycled without hesitation or binding and the distal suture was released.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 unreleased sutures may occur if the firing sequence is not completed.In this situation, the internal hinges which release the sutures may not engage fully and reinforcement material may not deploy properly.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: 9569337
• Report Number: 1219930-2020-00268
• Device Sequence Number: 13986475
• Product Code: GDW
• UDI-Device Identifier: 10884521543621
• UDI-Public: 10884521543621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• 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): 04/01/2020

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 Model Number: SIGTRS45AXT
• Device Catalogue Number: SIGTRS45AXT
• Device Lot Number: NH0179X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1