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

Model Number	3957
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
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, during sub total gastrectomy, they used instrument and the reload.The surgeon started firing the device, however the firing stopped at the last 1cm of the line.They replaced by new reload, and connected it to the same instrument ,however they could not fire the device at all.Then they replaced by new instrument and another new reload, and the device worked fine.The surgical time was extended by less than 30 min.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: 7788882
• Report Number: 1219930-2018-04518
• Device Sequence Number: 19126579
• 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
• Report Date (Section B): 08/16/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1