MAUDE Adverse Event Report: COVIDIEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK4XDPTSW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was taken to the operating room where she was placed in supine position.General anesthesia was induced.The abdomen was prepped and draped in the usual sterile fashion.Procedure started and the abdomen was insufflated.Trocars were inserted.Lysis of adhesions was performed initially.When it was time to use the reliatack fixation device, it was not functioning at all.Physician said that the mechanism on the end was not activating the tacks.The device was replaced with a similar device and the procedure was completed as planned.No patient harm.Manufacturer response for staple, implantable, reliatack (per site reporter).Device taken by medical representative.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16768221
• Report Number: 16768221
• Device Sequence Number: 3140116
• Product Code: GDW
• UDI-Device Identifier: 10884521726383
• UDI-Public: (01)10884521726383(17)250531(10)N2H0794Y
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/27/2023
• Report Date (Section F): 04/05/2023

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: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N2H0794Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 37 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 04/05/2023