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

Model Number	3948
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
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 sub-total gastrectomy procedure, on the second firing of the device, the surgeon attempted to fire the device, however, the handle was too stiff and the device was unable to fire.It seemed that the cartridge was damaged because the trigger was pressed strongly.The procedure was completed with another device.There was no patient injury.

• 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: 8389789
• Report Number: 1219930-2019-01288
• Device Sequence Number: 16525135
• Product Code: GDW
• UDI-Device Identifier: 20884521063157
• UDI-Public: 20884521063157
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885047
• 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
• Report Date (Section B): 03/05/2019

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 Model Number: 3948
• Device Catalogue Number: 3948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1