MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK5RDPT
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
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 a laparoscopic totally extra-peritoneal inguinal procedure, while on the last step of tacking in the mesh to secure repair, there was difficulty in pressing the "push to reload" button but navigating the lock and unlock button was fine.There was also difficulty articulating the device.The device jammed and would not fire.They tried to change reload and that would not load and fire.No tacks were able to be fired from the device.They had to open an entirely new box of the product and that new device performed as expected.There was no patient injury.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7288710
• Report Number: 1219930-2018-00983
• Device Sequence Number: 2273844
• Product Code: GDW
• UDI-Device Identifier: 20884521202402
• UDI-Public: 20884521202402
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 05/31/2019
• Device Model Number: RELTACK5RDPT
• Device Catalogue Number: RELTACK5RDPT
• Device Lot Number: N6E0533UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1