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

Model Number	RELTACK3X10SW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During case, the tacker locked up.No harm to patient.Another tacker opened to complete the case.Description of procedure: we then attached the mesh to the abdominal wall using approximately 40 absorbatacks placing them every 1 to 2 cm around the perimeter of the mesh followed by a double crown of tacks.A completion laparoscopic survey was performed.There were no complications.No bleeding or other abnormalities were noted.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8658016
• Report Number: 8658016
• Device Sequence Number: 2299802
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: (01)10884521726376(17)200930(10)N7J600UX
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019
• Report Date (Section F): 05/03/2019

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 Model Number: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Device Lot Number: N7J600UX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 05/03/2019