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

Model Number	RELTACK5RDPT
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
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 abdominal wall hernia, the reload inside the package with 8 tacks was loaded and fired, but the handle generated a strange crackling sound when squeezed, and 1/4 depth of the tack did not go into the tissue, and it was fixed ina status like floating.The second tack could be tacked into the tissue well, but in the following firings, the event occurred several times that 1/4 tack did not go into the tissue.Oozing bleeding occurred as a result of the issue.The surgical time was extended by less than 30 minutes.No patient injury.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8160382
• Report Number: 1219930-2018-06637
• Device Sequence Number: 2288104
• Product Code: GDW
• UDI-Device Identifier: 10884521202405
• UDI-Public: 10884521202405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 04/30/2020
• Device Model Number: RELTACK5RDPT
• Device Catalogue Number: RELTACK5RDPT
• Device Lot Number: N7D0646UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1