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 Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
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.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; therefore, a device history record will not be performed.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.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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 a cystectomy procedure when the surgeon gripped the tissue and tried to staple, the firing knob did not move at all and could not staple.To complete the procedure, another device was used.No patient injury or extension in surgical time.

• Brand Name: POLY GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6991044
• Report Number: 1219930-2017-08410
• Device Sequence Number: 11069724
• Product Code: GDW
• UDI-Device Identifier: 10884521047679
• UDI-Public: 10884521047679
• 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): 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 Expiration Date: 11/30/2017
• Device Model Number: 030775
• Device Catalogue Number: 030775
• Device Lot Number: N5E0521X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• 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