MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGLU45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
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 open lobectomy, when attempting to first fire across the lobe, the loading unit would go into firing mode with 2 different reloads but the handle was not able to fire.It was noted that the surgeon was not able to press the green button but was able to squeeze the handle.Another reload was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned loading unit noted that the channel c onnectors of the loading unit were bent away from the inside channel wall of the loading unit.Loading unit came with a cartridge attached.Functionally, the attached cartridge was removed with ease.The loading unit was able to communicate with the representative handle but was unable to recognize a new staple cartridge.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 bent channel connectors of the loading unit may be replicated during inadequate/unsuccessful loading attempts.The root cause of the observed damage was misuse of the product 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: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8303532
• Report Number: 1219930-2019-00694
• Device Sequence Number: 62773
• Product Code: GDW
• UDI-Device Identifier: 10884521543492
• UDI-Public: 10884521543492
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 10/31/2022
• Device Model Number: SIGLU45A
• Device Catalogue Number: SIGLU45A
• Device Lot Number: N7K0372X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1