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); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the patient underwent a laparoscopic intraperitoneal onlay mesh repair (ipom) procedure.The reloadable tacking devices were used to tack the mesh to the abdominal wall.A second operation was required six days after the original procedure.There was injury as a result of the event, tacks were in the cavity of the patient.Twelve tacks fell into the cavity of the patient.There may be more tacks.The patient outcome is reported has no injury.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 7302917
• Report Number: 1219930-2018-01122
• Device Sequence Number: 13926490
• Product Code: GDW
• UDI-Device Identifier: 20884521202419
• UDI-Public: 20884521202419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: RELTACK5R
• Device Catalogue Number: RELTACK5R
• Device Lot Number: N6H0057UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention