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

Model Number	030775
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the stapler was received with a full complement of staples.The interlock was engaged.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.Replication of the reported condition may occur if the firing knob is retracted prior to advancing.When the firing knob is retracted before firing the stapler it engages with the interlock in the handle and prevents the instrument from firing.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: during cystectomy/ileal conduit, the surgeon clamped the tissue of small intestine and tried to push the firing knob, however it was stiff and could not fire the device at all.Replaced by a new device, the procedure was completed.No injury to the patient.

• Brand Name: POLY GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7320076
• Report Number: 1219930-2018-01240
• Device Sequence Number: 105225
• Product Code: GDW
• UDI-Device Identifier: 20884521047676
• UDI-Public: 20884521047676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843603
• 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): 03/07/2018

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 Expiration Date: 09/30/2019
• Device Model Number: 030775
• Device Catalogue Number: 030775
• Device Lot Number: N7C0362X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1