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

Model Number	RELTACK5R
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
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 laparoscopic inguinal hernia procedure, while attempting to fixate the mes to the bony prominence, the first device with the reload did not penetrate the bone as desired.The second device with second reload was used but the surgeon was not satisfied with the fixation to the bone and surgeon was aware of some bleeding at the site on the second application.Surgeon used a third device which is different now the initial devices that was used, it was applied to the same surgical site and the surgeon was satisfied with the fixation achieved.The procedure was completed using the third instrument.The feedback was that the first two instrument were not articulated during the first two applications.There was 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: 7382926
• Report Number: 1219930-2018-01791
• Device Sequence Number: 128247
• Product Code: GDW
• UDI-Device Identifier: 20884521202419
• UDI-Public: 20884521202419
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: 11/30/2019
• Device Model Number: RELTACK5R
• Device Catalogue Number: RELTACK5R
• Device Lot Number: N6L0060UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR