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

Model Number	3957
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
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 the first firing of bypass of gastroenterostomy, at jejunum resection (lifted-up jejunum construction) , the cartridge was connected to the instrument, then the surgeon started firing the device, however the knife advanced by only 1cm then the firing stopped.The staples of the proximal end appeared from the staple pockets, but they did not form.Replaced by new cartridge , and connected the same instrument ,and the firing was successful.At the same procedure ,the customer found a gray plastic piece was attached to the device.They could not identify where this foreign material came from.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7732503
• Report Number: 1219930-2018-04166
• Device Sequence Number: 752158
• Product Code: GDW
• UDI-Device Identifier: 10884521064607
• UDI-Public: 10884521064607
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885222
• 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): 10/02/2018

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: 3957
• Device Catalogue Number: 3957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1