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.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of two devices.Two (2) fully fired 5r device loading unit (dlu)s were received.The first dlu had proper timing and no scratches on the inner tube.The second dlu had disrupted timing and scratches on the inner tube of one of the dlus.Functional testing was precluded since the dlus were fully fired.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported conditions could be due to improper loading of the reloads, indicated by the scratches on the inner tube of the reloads.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: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7382836
• Report Number: 1219930-2018-01788
• Device Sequence Number: 173589
• 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,Followup
• Report Date (Section B): 05/23/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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