MAUDE Adverse Event Report: US SURGICAL (INACTIVE) ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030450
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously reported to the fda on a summary report and is now being submitted on a 3500a per fda request.Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination noted that the loading unit was prefired.The jaws of the loading unit were clamped and the knife bar assembly was slightly advanced.The jaws were manually opened and functional testing was completed with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Staple pre-fire and/or inability to open the jaws after clamping may occur under the following conditions.The shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod extended.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the sulu engages in the instrument to facilitate clamping and unclamping.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter , prior to use on patient the anvil cannot open prior to use.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL (INACTIVE); 60 middletown ave; north haven CT 06473
• MDR Report Key: 6991006
• Report Number: 1219930-2017-08408
• Device Sequence Number: 19131843
• Product Code: GDW
• UDI-Device Identifier: 10884523002812
• UDI-Public: 10884523002812
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 030450
• Device Catalogue Number: 030450
• Device Lot Number: N4B0530LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1