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

Model Number	RELTACK3X10SW
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
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, while tacking the mesh during a laparoscopic ventral hernia repair, there were difficulties with loading the reload onto the handle and the tacks fell off the mesh onto the viscera of the patient.They opened up a new tacker to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three photographs of one articulating reloadable instrument.One photographs noted a surgical procedure with two loose tacks on the tissue.The device was not visible in the photograph.The other two photographs confirmed the lot number as reported.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.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 mc dermott rd; north haven CT 06473
• MDR Report Key: 7651425
• Report Number: 1219930-2018-03518
• Device Sequence Number: 14056717
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: 10884521726376
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/15/2018

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: 09/30/2020
• Device Model Number: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Device Lot Number: N7J0600UX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1