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

Model Number	SIG30AV
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
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 a lobectomy procedure, the surgeon tried to fire, but the handle could not be squeezed and the device could not be fired.The procedure was completed with another device.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was pre-fired and engaged in interlock.There were staples protruding from proximal staple cartridge channel.Functionally the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was applied to test media with proper staple placement and media transection.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 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: 8810125
• Report Number: 1219930-2019-04264
• Device Sequence Number: 3026749
• Product Code: GDW
• UDI-Device Identifier: 20884521543673
• UDI-Public: 20884521543673
• 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): 09/11/2019

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: 10/31/2023
• Device Model Number: SIG30AV
• Device Catalogue Number: SIG30AV
• Device Lot Number: N8L0785Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/21/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1