MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG POLY GIA; STAPLE, IMPLANTABLE

Model Number	030775
Medical Device Problem Codes	Physical Resistance (2578); Failure to Fire (2610); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that a device issue occurred during a cystectomy / ileal conduit procedure.After opening the packaging and setting up the device, the setting was not smooth and the handle was stiff.The surgeon tried to fire the device, but it did not work.The procedure was completed with another device.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The returned product was received with a full complement of staples and the interlock was engaged.There were no other visual or functional abnormalities observed during product analysis.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.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.

• Brand Name: POLY GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7036234
• Report Number: 1219930-2017-08800
• Device Sequence Number: 1145340
• 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,Followup
• Report Date (Section B): 02/01/2018

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: 02/29/2020
• Device Model Number: 030775
• Device Catalogue Number: 030775
• Device Lot Number: N7H0745X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1